The Recall Desk

Hazard

Test Failure recalls

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

What the numbers show

Total
29
Critical
0
Severe
0
Most recent
2026-07-15

Of the 29 test failure 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 test failure 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.

26–29 of 29

  • ModerateFDA (Devices)·Z-2577-2018·2018-08-15

    Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure

    Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.

    Product
    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3075-2017·2017-09-06

    BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.

    Product
    VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2559-2014·2014-09-03

    Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits

    Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.

    Product
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2236-2014·2014-08-20

    Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles

    Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.

    Product
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to ge
    Category
    Medical Device
    Distribution
    Distributed nationwide