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SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit

MP BIOMEDICALS, LLC · Model 06B264806 · UDI-DI 00817830022597

CGN Prescription
1
510(k) clearances
152
Adverse events
28
Recalls
34
Facilities

Description

Radioimmunoassay for the quantitative determination of Vitamin B12 and Folate in human plasma or serum.

Recalls

DateFirmReason
2024-07-03Ortho-Clinical Diagnostics, Inc.It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2023-01-09Siemens Healthcare Diagnostics, Inc.Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
2019-07-22Siemens Healthcare Diagnostics, IncHomocysteine Assay May Cause Elevated Results in the Folate Assay
2019-07-22Siemens Healthcare Diagnostics, IncHomocysteine Assay May Cause Elevated Results in the Folate Assay
2019-07-22Siemens Healthcare Diagnostics, IncHomocysteine Assay May Cause Elevated Results in the Folate Assay
2018-11-30Tosoh Bioscience Inc
2018-07-12Ortho Clinical Diagnostics IncThe recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated
2018-01-02Siemens Healthcare Diagnostics, Inc.Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirol

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.