The Recall Desk

Hazard

Specimen Interference recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2025-12-24

Of the 3 specimen interference 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 specimen interference 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.

1–3 of 3

  • HighFDA (Devices)·Z-0959-2026·2025-12-24

    Leukemia test kits recalled in a second lot family over inaccurate results

    Cepheid is recalling 6,325 Xpert BCR-ABL Ultra kits, catalog GXBCRABL-US-10, because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0960-2026·2025-12-24

    Leukemia test kits recalled over inaccurate results with high white cell counts

    Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-2613-2017·2017-06-28

    Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference

    Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.

    Product
    ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide