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  "name": "ADVIA Centaur Folate 500 test kit-\tFor in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.  Siemens Material Number (SMN): 10325366",
  "description": "FDA recall Z-1153-2023 — Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Folate 500 test kit-\tFor in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.  Siemens Material Number (SMN): 10325366 (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": "ADVIA Centaur Folate 500 test kit-\tFor in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.  Siemens Material Number (SMN): 10325366",
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      "name": "FDA recall Z-1153-2023: Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Folate 500 test kit-\tFor in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.  Siemens Material Number (SMN): 10325366",
      "text": "The FDA logged enforcement record Z-1153-2023: Siemens Healthcare Diagnostics, Inc. is voluntarily recalling ADVIA Centaur Folate 500 test kit-\tFor in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.  Siemens Material Number (SMN): 10325366 — reason: Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-09. Affected lots/codes: UDI:    (01)00630414450940(10)16276336 (17)20230320;       (01)00630414450940(10)21334336(17)20230320;       (01)00630414450940(10)22079336(17)20230320;       (01)00630414450940(10)27946338(17)20230529;      (01)00630414450940(10)41225342(17)20230630;       (01)00630414450940(10)62966344 (17)20230726;    Lot Numbers: 16276336,  21334336, 22079336, 27946338, 41225342, 62966344 and higher.   Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated.. A RECORDED FDA enforcement action (occurred=true).",
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        "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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      "name": "FDA classified recall Z-1153-2023 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.",
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      "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."
    },
    {
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      "@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.",
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      "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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            "Value": "Siemens Healthcare Diagnostics, Inc.",
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            "Field": "Reason",
            "Value": "Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.",
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            "Value": "UDI:    (01)00630414450940(10)16276336 (17)20230320;       (01)00630414450940(10)21334336(17)20230320;       (01)00630414450940(10)22079336(17)20230320;       (01)00630414450940(10)27946338(17)20230529;      (01)00630414450940(10)41225342(17)20230630;       (01)00630414450940(10)62966344 (17)20230726;    Lot Numbers: 16276336,  21334336, 22079336, 27946338, 41225342, 62966344 and higher.   Affects all current and future lots of the ADVIA Centaur Folate assay assay until the Instructions for Use are updated.",
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            "Field": "Distribution pattern",
            "Value": "Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Kenya¿¿¿¿¿¿¿¿¿¿ Latvia¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Malta¿¿¿¿¿¿¿¿¿¿ Morocco¿¿¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Oman¿¿¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Saudi¿Arabia¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ Uganda¿¿¿¿¿¿¿¿¿ Ukraine¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿  Country              AR                   AU                   BR                   BS                   CA                   CL                   CN                   CO                   CR                   DO                   EC                   HK                   IL                   IN                   JP                   KR                   MX                   MY                   NZ                   PE                   PH                   PY                   SA                   SG                   TH                   TW                   UY                   VN                   ZA",
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