The Recall Desk

Hazard

Reagent Stability recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2018-12-26

Of the 4 reagent stability 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 reagent stability 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.

1–4 of 4

  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.

    Product
    VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
Reagent Stability recalls · The Recall Desk