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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0215-2026.jsonld",
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  "name": "DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)",
  "description": "FDA recall Z-0215-2026 — Beckman Coulter, Inc. is recalling DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252) (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. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0215-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)",
    "manufacturer": {
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      "name": "Beckman Coulter, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0215-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0215-2026: Beckman Coulter, Inc. is recalling DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)",
      "text": "The FDA logged enforcement record Z-0215-2026: Beckman Coulter, Inc. is voluntarily recalling DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252) — reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already \"In Progress\" using the same \"Sample ID number\". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-19. Affected lots/codes: C63522 UDI-DI: 14987666545089; C63521 UDI-DI: 14987666545072; C13252 UDI-DI: 15099590742331;  Serial Numbers: 750198 750058 750222 750128 750138 750069 750050 750055 750179 750180 750181 750109 750168 750104 750211 750073 750210 750209 750178 750151 750153 750152 750155 750185 750187 750188 750195 750196 750201 750197 750199 750204 750202 750205 750083 750079 750186 750052 750230 750228 750140 750077 750135 750130 750167 750095 750105 750175 750132 750082 750113 750221 750219 750100 750099 750174 750053 750246 750134 750217 750216 750236 750233 750143 750081 750085 750071 750208 750207 750076 750131 750148 750223 750137 750116 750166 750241 750240 750183 750193 750200 750070 750087 750239 750107 750093 750124 750215 750141 750145 750144 750117 750108 750184 750173 750224 750218 750123 750129 750054 750206 750146 750101 750112 750194 750115 750157 750159 750160 750162 750125 750103 750229 750226 750234 750133 750048 750163 750182 750192 750189 750158 750250 750214 750110 750247 750154 750080 750251 750232 750231 750255 750238 750253 750074 750047 750102 750147 750142 750092 750094 750164 750165 750225 750212 750064 750065 750177 750086 750088 750042 750043 750254 750044 750056 750169 750045 750057 750127 750156. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0215-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0215-2026/fda-classification",
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      "name": "FDA classified recall Z-0215-2026 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
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-0215-2026&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-0215-2026/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": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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."
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      "name": "FDA recall details — Z-0215-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-0215-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Beckman Coulter, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already \"In Progress\" using the same \"Sample ID number\". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-19",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "C63522 UDI-DI: 14987666545089; C63521 UDI-DI: 14987666545072; C13252 UDI-DI: 15099590742331;  Serial Numbers: 750198 750058 750222 750128 750138 750069 750050 750055 750179 750180 750181 750109 750168 750104 750211 750073 750210 750209 750178 750151 750153 750152 750155 750185 750187 750188 750195 750196 750201 750197 750199 750204 750202 750205 750083 750079 750186 750052 750230 750228 750140 750077 750135 750130 750167 750095 750105 750175 750132 750082 750113 750221 750219 750100 750099 750174 750053 750246 750134 750217 750216 750236 750233 750143 750081 750085 750071 750208 750207 750076 750131 750148 750223 750137 750116 750166 750241 750240 750183 750193 750200 750070 750087 750239 750107 750093 750124 750215 750141 750145 750144 750117 750108 750184 750173 750224 750218 750123 750129 750054 750206 750146 750101 750112 750194 750115 750157 750159 750160 750162 750125 750103 750229 750226 750234 750133 750048 750163 750182 750192 750189 750158 750250 750214 750110 750247 750154 750080 750251 750232 750231 750255 750238 750253 750074 750047 750102 750147 750142 750092 750094 750164 750165 750225 750212 750064 750065 750177 750086 750088 750042 750043 750254 750044 750056 750169 750045 750057 750127 750156",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
          }
        }
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}