The Recall Desk

Hazard

Invalid Calibration recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2020-12-23

Of the 6 invalid calibration recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all invalid calibration recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • ModerateFDA (Devices)·Z-0634-2021·2020-12-23

    Roche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination

    Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.

    Product
    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0103-2021·2020-10-21

    Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues

    Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.

    Product
    Tina-quant Complement C4 ver.2, Catalog 05991994190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0152-2020·2019-10-23

    Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits

    Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.

    Product
    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0153-2020·2019-10-23

    Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues

    Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.

    Product
    Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2018·2018-08-08

    bioMerieux Recalls VIDAS LH Test Kits Due to Calibration Issues

    bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.

    Product
    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Lin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2013·2013-05-29

    Ortho-Clinical Diagnostics Recalls VITROS CK-MB Calibrators Due to Invalid Results

    Ortho-Clinical Diagnostics is recalling VITROS CK-MB Calibrators because internal testing found that improperly stored units generated invalid calibrations.

    Product
    VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide