{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0429-2026.jsonld", "@type": "schema:Dataset", "name": "Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer", "description": "FDA recall Z-0429-2026 — Beckman Coulter, Inc. is recalling Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. 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Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-01. Affected lots/codes: 973100, UDI/DI 15099590265373 (Chaska), Serial numbers: 610458, 610455, 610679, 610579, 610432, 610430, 610434, 610664, 610682, 610765, 610500, 610541, 610544, 610545, 610562, 610547, 610585, 610595, 610475, 610453, 610781, 610580, 610444, 610704, 610586, 610684, 610589, 610588, 610493, 610659, 610570, 610498, 610748, 610496, 610560, 610573, 610574, 610577, 610601, 610651, 610680, 610642, 610641, 610683, 610747, 610468, 610772, 610441, 610476, 610489, 610488, 610492, 610532, 610534, 610533, 610535, 610640, 610457, 610464, 610790, 610559, 610687, 610571, 610552, 610555, 610582, 610531, 610568, 610594, 610773, 610490, 610668, 610784, 610812, 610556, 610550, 610600, 610565, 610558, 610557, 610551, 610527, 610685, 610730, 610686, 610494, 610753, 610590, 610593, 610546, 610724, 610538, 610540, 610439, 610491, 610581, 610649, 610466, 610789, 610723, 610575, 610443, 610776, 610734, 610518, 610519, 610517, 610520, 610563, 610569, 610787, 610459, 610775, 610572, 610561, 610597, 610445, 610440, 610567, 610596, 610497, 610774, 610454, 610426, 610431, 610442, 610433, 610435, 610539, 610578, 610509, 610418, 610483, 610484, 610515, 610425, 610503, 610510, 610452, 610526, 610602, 610481, 610487, 610482, 610507, 610505, 610506, 610514, 610499, 610504, 610511, 610423, 610524, 610525, 610512, 610564, 610424, 610513, 610480, 610516, 610521, 610419, 610415, 610416, 610456, 610461, 610460, 610472, 610470, 610477, 610471, 610463, 610462, 610467, 610469, 610465, 610587, 610639, 610614, 610616, 610608, 610605, 610645, 610634, 610623, 610626, 610615, 610633, 610622, 610609, 610621, 610672, 610678, 610674, 610671, 610667, 610673, 610675, 610677, 610650, 610662, 610692, 610646, 610693, 610652, 610661, 610663, 610654, 610655, 610689, 610653, 610656, 610657, 610694, 610688, 610658, 610660, 610725, 610729, 610732, 610731, 610719, 610726, 610703, 610709, 610718, 610715, 610717, 610716, 610698, 610702, 610714, 610711, 610705, 610706, 610697, 610710, 610755, 610757, 610754, 610756, 610767, 610766, 610769, 610768, 610785, 610788, 610800, 610793, 610794, 610795, 610801, 610814, 610811, 610758, 610786, 610744, 610804, 610736, 610737, 610742, 610750, 610802, 610806, 610791, 610759, 610762, 610738, 610739, 610740, 610741, 610792, 610805, 610808, 610733, 610761, 610763, 610798, 610803, 610735, 610810, 610760, 610749, 610799, 610809, 610764, 610745, 610743, 610746, 610829, 610832, 610833, 610830, 610831, 610827, 610828, 610825, 610826, 610822, 610807, 610813, 610821. UDI/DI 16954701000412 (Suzhou), Serial Numbers: 630104, 630105, 630160, 630159, 630162, 630110, 630140, 630175, 630143, 630103, 630108, 630174, 630099, 630112, 630113, 630136, 630107, 630102, 630100, 630106, 630115, 630114, 630132, 630111, 630101, 630109, 630146, 630139, 630116, 630126, 630117, 630118, 630120, 630119, 630121, 630122, 630123, 630124, 630125, 630129, 630128, 630130, 630131, 630134, 630135, 630137, 630141, 630142, 630133, 630127, 630164, 630172, 630173, 630144, 630156, 630145, 630157, 630158, 630155, 630154, 630149, 630152, 630170, 630171, 630150, 630151, 630153, 630163, 630148, 630147, 630138, 630194, 630197, 630202, 630203, 630178, 630184, 630166, 630186, 630182, 630176, 630205, 630179, 630180, 630181, 630195, 630187, 630161, 630169, 630167, 630165, 630193, 630191, 630192, 630190, 630177, 630188, 630183, 630196, 630199, 630168, 630219, 630208, 630217, 630230, 630223, 630214, 630210, 630235, 630232, 630201, 630226, 630227, 630218, 630233, 630221, 630222, 630216, 630215, 630206, 630207, 630211, 630231, 630209, 630224, 630234, 630228, 630220, 630225, 630229, 630204, 630212, 630213, 630259, 630260, 630252, 630281, 630282, 630272, 630265, 630279, 630256, 630255, 630269, 630242, 630248, 630241, 630264, 630275, 630270, 630249, 630253, 630271, 630267, 630278, 630254, 630263, 630243, 630246, 630273, 630280, 630238, 630251, 630257, 630258, 630274, 630240, 630244, 630247, 630262, 630237, 630266, 630236, 630261, 630245, 630307, 630300, 630301, 630315, 630284, 630319, 630327, 630296, 630292, 630304, 630305, 630311, 630310, 630312, 630324, 630291, 630321, 630323, 630325, 630289, 630316, 630317, 630308, 630306, 630318, 630299, 630314, 630302, 630313, 630290, 630285, 630298, 630293, 630295, 630303, 630320, 630309, 630294, 630287, 630286, 630331, 630288, 630322, 630328, 630337, 630351, 630341, 630345, 630344, 630343, 630342, 630340, 630334, 630330, 630332, 630336, 630338, 630333, 630339, 630347, 630346, 630348, 630326, 630198, 630189, 630276, 630353, 630185, 630352, 630329, 630277, 630283, 630297, 630349, 630200, 630239.. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0429-2026&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0429-2026&lang=eng" } }, "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0429-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0429-2026 as Class II", "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0429-2026&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0429-2026&lang=eng" } }, "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0429-2026/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-0429-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0429-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Beckman Coulter, Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-10-01", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "973100, UDI/DI 15099590265373 (Chaska), Serial numbers: 610458, 610455, 610679, 610579, 610432, 610430, 610434, 610664, 610682, 610765, 610500, 610541, 610544, 610545, 610562, 610547, 610585, 610595, 610475, 610453, 610781, 610580, 610444, 610704, 610586, 610684, 610589, 610588, 610493, 610659, 610570, 610498, 610748, 610496, 610560, 610573, 610574, 610577, 610601, 610651, 610680, 610642, 610641, 610683, 610747, 610468, 610772, 610441, 610476, 610489, 610488, 610492, 610532, 610534, 610533, 610535, 610640, 610457, 610464, 610790, 610559, 610687, 610571, 610552, 610555, 610582, 610531, 610568, 610594, 610773, 610490, 610668, 610784, 610812, 610556, 610550, 610600, 610565, 610558, 610557, 610551, 610527, 610685, 610730, 610686, 610494, 610753, 610590, 610593, 610546, 610724, 610538, 610540, 610439, 610491, 610581, 610649, 610466, 610789, 610723, 610575, 610443, 610776, 610734, 610518, 610519, 610517, 610520, 610563, 610569, 610787, 610459, 610775, 610572, 610561, 610597, 610445, 610440, 610567, 610596, 610497, 610774, 610454, 610426, 610431, 610442, 610433, 610435, 610539, 610578, 610509, 610418, 610483, 610484, 610515, 610425, 610503, 610510, 610452, 610526, 610602, 610481, 610487, 610482, 610507, 610505, 610506, 610514, 610499, 610504, 610511, 610423, 610524, 610525, 610512, 610564, 610424, 610513, 610480, 610516, 610521, 610419, 610415, 610416, 610456, 610461, 610460, 610472, 610470, 610477, 610471, 610463, 610462, 610467, 610469, 610465, 610587, 610639, 610614, 610616, 610608, 610605, 610645, 610634, 610623, 610626, 610615, 610633, 610622, 610609, 610621, 610672, 610678, 610674, 610671, 610667, 610673, 610675, 610677, 610650, 610662, 610692, 610646, 610693, 610652, 610661, 610663, 610654, 610655, 610689, 610653, 610656, 610657, 610694, 610688, 610658, 610660, 610725, 610729, 610732, 610731, 610719, 610726, 610703, 610709, 610718, 610715, 610717, 610716, 610698, 610702, 610714, 610711, 610705, 610706, 610697, 610710, 610755, 610757, 610754, 610756, 610767, 610766, 610769, 610768, 610785, 610788, 610800, 610793, 610794, 610795, 610801, 610814, 610811, 610758, 610786, 610744, 610804, 610736, 610737, 610742, 610750, 610802, 610806, 610791, 610759, 610762, 610738, 610739, 610740, 610741, 610792, 610805, 610808, 610733, 610761, 610763, 610798, 610803, 610735, 610810, 610760, 610749, 610799, 610809, 610764, 610745, 610743, 610746, 610829, 610832, 610833, 610830, 610831, 610827, 610828, 610825, 610826, 610822, 610807, 610813, 610821. UDI/DI 16954701000412 (Suzhou), Serial Numbers: 630104, 630105, 630160, 630159, 630162, 630110, 630140, 630175, 630143, 630103, 630108, 630174, 630099, 630112, 630113, 630136, 630107, 630102, 630100, 630106, 630115, 630114, 630132, 630111, 630101, 630109, 630146, 630139, 630116, 630126, 630117, 630118, 630120, 630119, 630121, 630122, 630123, 630124, 630125, 630129, 630128, 630130, 630131, 630134, 630135, 630137, 630141, 630142, 630133, 630127, 630164, 630172, 630173, 630144, 630156, 630145, 630157, 630158, 630155, 630154, 630149, 630152, 630170, 630171, 630150, 630151, 630153, 630163, 630148, 630147, 630138, 630194, 630197, 630202, 630203, 630178, 630184, 630166, 630186, 630182, 630176, 630205, 630179, 630180, 630181, 630195, 630187, 630161, 630169, 630167, 630165, 630193, 630191, 630192, 630190, 630177, 630188, 630183, 630196, 630199, 630168, 630219, 630208, 630217, 630230, 630223, 630214, 630210, 630235, 630232, 630201, 630226, 630227, 630218, 630233, 630221, 630222, 630216, 630215, 630206, 630207, 630211, 630231, 630209, 630224, 630234, 630228, 630220, 630225, 630229, 630204, 630212, 630213, 630259, 630260, 630252, 630281, 630282, 630272, 630265, 630279, 630256, 630255, 630269, 630242, 630248, 630241, 630264, 630275, 630270, 630249, 630253, 630271, 630267, 630278, 630254, 630263, 630243, 630246, 630273, 630280, 630238, 630251, 630257, 630258, 630274, 630240, 630244, 630247, 630262, 630237, 630266, 630236, 630261, 630245, 630307, 630300, 630301, 630315, 630284, 630319, 630327, 630296, 630292, 630304, 630305, 630311, 630310, 630312, 630324, 630291, 630321, 630323, 630325, 630289, 630316, 630317, 630308, 630306, 630318, 630299, 630314, 630302, 630313, 630290, 630285, 630298, 630293, 630295, 630303, 630320, 630309, 630294, 630287, 630286, 630331, 630288, 630322, 630328, 630337, 630351, 630341, 630345, 630344, 630343, 630342, 630340, 630334, 630330, 630332, 630336, 630338, 630333, 630339, 630347, 630346, 630348, 630326, 630198, 630189, 630276, 630353, 630185, 630352, 630329, 630277, 630283, 630297, 630349, 630200, 630239.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide", "Status": "recorded" } } ] } ] }