The Recall Desk

Hazard

Assay Reagent recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2025-07-23

Of the 2 assay reagent 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 assay reagent 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.

1–2 of 2

  • HighFDA (Devices)·Z-2115-2025·2025-07-23

    Access Vitamin B12 reagent lot can give erroneously low or high results

    Access Vitamin B12 Reagent lot 439850 is being recalled after complaints of erroneous results, which may lead to a delayed or improper diagnosis or repeat testing. 10,000 units are affected.

    Product
    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2073-2025·2025-07-09

    VITROS opiate reagent lots may give low quality control results

    VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.

    Product
    VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide