The Recall Desk

Hazard

Performance Deviation recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2026-03-25

Of the 5 performance deviation 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 performance deviation 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.

1–5 of 5

  • HighFDA (Devices)·Z-1565-2026·2026-03-25

    Abbott ID NOW influenza test lot shows higher invalid result rates

    Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.

    Product
    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0306-2018·2018-01-10

    Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation

    Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.

    Product
    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1788-2014·2014-06-25

    Kerr Recalls Tytin Dental Restorative Material Due to Fast Setting

    Kerr Corporation is recalling one lot of Tytin Regular Set dental restorative material because it may set faster than specified in the Directions for Use.

    Product
    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2013·2013-04-17

    Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity

    Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.

    Product
    Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
    Category
    Medical Device
    Distribution
    Distributed nationwide