Single (Specified) Analyte Controls (Assayed And Unassayed)

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

• 2025-05-27Open, ClassifiedStorage

  SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

• 2025-05-27Open, ClassifiedStorage

  HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

  transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

• 2024-06-04Open, ClassifiedNonconforming Material/Component

  VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872

  The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.

• 2024-03-19Open, ClassifiedStorage

  Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

  Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

• 2023-07-21Open, ClassifiedUnder Investigation by firm

  VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

  May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

• 2023-02-21Open, ClassifiedUnder Investigation by firm

  ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308

  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

  ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366

  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

  ADVIA Centaur Folate 500 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): 10331250 Siemens Material Number (SMN): 10325366

  Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

• 2020-09-14TerminatedUnder Investigation by firm

  Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

  Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.

• 2015-11-23TerminatedLabeling False and Misleading

  CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

  CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.