The Recall Desk

Hazard

Test Inaccuracy recalls

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

What the numbers show

Total
55
Critical
0
Severe
1
Most recent
2026-04-29

Of the 55 test inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) 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 inaccuracy 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.

51–55 of 55

  • ModerateFDA (Devices)·Z-1448-2015·2015-04-22

    Vitrolife Recalls SpermMAR IgA Test Kits Due to Sperm Motility Reduction

    Vitrolife Inc is recalling 45 kits of SpermMAR IgA test because a new formulation reduces sperm cell motility in certain samples.

    Product
    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermM
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0152-2014·2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2013·2013-09-25

    Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues

    Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.

    Product
    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0738-2013·2013-02-06

    bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors

    bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.

    Product
    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Category
    Medical Device
    Distribution
    29 states