The Recall Desk

Hazard

Product Instability recalls

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

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2020-11-25

Of the 9 product instability 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 product instability 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.

1–9 of 9

  • LowFDA (Devices)·Z-0471-2021·2020-11-25

    Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.

    Product
    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2020·2020-01-01

    Ortho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability

    Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.

    Product
    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2279-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1877-2016·2016-06-08

    Leica Microsystems Recalls Unstable CDX2 Antibody Lots

    Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1876-2016·2016-06-08

    Leica Novocastr Antibody Recalled for Stability Issues

    Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2015·2015-04-29

    DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability

    DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient results.

    Product
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized w
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1059-2013·2013-04-10

    Polymedco OC-Light iFOBT Test Strips Recalled for Potential False Negatives

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide