Acid, Folic, Radioimmunoassay
FDA adverse event reports and recall history for acid, folic, radioimmunoassay (product code CGN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 150
- Deaths
- 0
- Injuries
- 3
- Malfunctions
- 146
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-08-12Open, ClassifiedSoftware Design Change
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
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 the increase in "TM5-4MB" condition codes which lead to a delay of results.
- 2023-02-21Open, ClassifiedUnder Investigation by firm
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- 2023-02-21Open, ClassifiedUnder Investigation by firm
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- 2023-02-21Open, ClassifiedUnder Investigation by firm
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- 2020-01-21TerminatedDevice Design
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Homocysteine Assay May Cause Elevated Results in the Folate Assay
- 2020-01-21TerminatedDevice Design
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Homocysteine Assay May Cause Elevated Results in the Folate Assay
- 2020-01-21TerminatedDevice Design
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Homocysteine Assay May Cause Elevated Results in the Folate Assay
- 2018-05-04TerminatedError in labeling
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid
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 Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
- 2018-05-04TerminatedError in labeling
ADVIA Centaur Folate (FOL)
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 Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
- 2015-09-04TerminatedProcess design
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
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