The Recall Desk

Hazard

Invalid Test Result 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
2024-04-03

Of the 5 invalid test result 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 invalid test result 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-1371-2024·2024-04-03

    Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens

    Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.

    Product
    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Recons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2021·2021-05-05

    Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk

    Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.

    Product
    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2019·2019-05-22

    Opgen Recalls GNR PNA FISH Control Slides Due to Performance Issues

    Opgen Inc is recalling 80 GNR PNA FISH Control Slides because they may show diminished performance before expiration, potentially causing invalid test results.

    Product
    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Lig
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1394-2017·2017-03-08

    BD AffirM VPIII Microbial Identification Test Recalled for Invalid Results

    Becton Dickinson is recalling specific lots of the BD AffirM VPIII Microbial Identification Test because blue speckles or fibers may cause invalid test results.

    Product
    BD AffirM VPIII Microbial Identification Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1812-2013·2013-08-07

    BD Affirm VPIII Microbial Identification Tests Recalled for Invalid Control Results

    Becton Dickinson is recalling 177 kits of BD Affirm VPIII Microbial Identification Tests because they may exhibit invalid internal negative control results.

    Product
    BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII
    Category
    Medical Device
    Distribution
    Distributed nationwide