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ARCHITECT
ABBOTT IRELAND · Model 1P74-37 · UDI-DI 00380740002152
10
510(k) clearances
150
Adverse events
28
Recalls
34
Facilities
Description
ARCHITECT Folate Reagent Kit (500T)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-03 | Ortho-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 |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2019-07-22 | Siemens Healthcare Diagnostics, Inc | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| 2019-07-22 | Siemens Healthcare Diagnostics, Inc | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| 2019-07-22 | Siemens Healthcare Diagnostics, Inc | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2018-07-12 | Ortho Clinical Diagnostics Inc | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated |
| 2018-01-02 | Siemens 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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Get your free API keyRead the docsData 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.