Home › Device types › CGN
Acid, Folic, Radioimmunoassay
FDA product code CGN · Class 2 · Clinical Chemistry
52
Registered devices
150
Adverse events
28
Recalls
64
510(k) clearances
Devices with this code
Atellica™ IM Fol DTT/Releasing Agent — Siemens Healthcare Diagnostics Inc.AIA-PACK RBC FOLATE — TOSOH CORPORATIONIMMULITE® Systems Dualcount™ Ascorbic Acid FOL — Siemens Healthcare Diagnostics Inc.Access Folate — Beckman Coulter, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSAtellica IM Fol — Siemens Healthcare Diagnostics Inc.AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONAIA-PACK RBC FOLATE HEMOLYZING REAGENT SET — TOSOH CORPORATIONAIA-PACK Folate — TOSOH CORPORATIONADVIA Centaur® FOL — Siemens Healthcare Diagnostics Inc.SimulTRAC-S Vitamin B12/Folate 125I RIA Kit — MP BIOMEDICALS, LLCAlinity — ABBOTT IRELANDAtellica™ IM Fol — Siemens Healthcare Diagnostics Inc.Atellica™ IM Fol DIL — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT IRELANDADVIA Centaur® FOL Ascorbic Acid Diluent DIL — Siemens Healthcare Diagnostics Inc.SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit — MP BIOMEDICALS, LLCARCHITECT — ABBOTT IRELANDIMMULITE® 2000 Systems FOL Folic Acid — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems FVB Vitamin B12/Folic Acid Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAIA-PACK Folate Pretreatment Set — TOSOH CORPORATIONADVIA Centaur® FOL DTT/Releasing Agent — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT IRELANDAIA-PACK RBC FOLATE PRETREATMENT SET — TOSOH CORPORATION
Recent 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-treatm |
| 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 |
| 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 |
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