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Folate AccuLite CLIA Test System -192 Wells

MONOBIND, INC. · Model 7575-300 · UDI-DI 00816870022017

CGN Prescription
10
510(k) clearances
150
Adverse events
28
Recalls
34
Facilities

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.