The Recall Desk

Hazard

Calibration Failure recalls

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

What the numbers show

Total
79
Critical
0
Severe
0
Most recent
2025-10-15

Of the 79 calibration failure 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 calibration failure 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.

76–79 of 79

  • HighFDA (Devices)·Z-1951-2013·2013-08-21

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues

    Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.

    Product
    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2013·2013-07-03

    Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures

    Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.

    Product
    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentratio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1161-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls Vitros Anti-HBs Reagent Packs Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling specific lots of Vitros Anti-HBs Reagent Packs because they may fail to obtain a valid calibration.

    Product
    VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2012·2012-09-05

    Siemens Stratus CS Acute Care D-dimer Calibrator Recall

    Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.

    Product
    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)
    Category
    Medical Device
    Distribution
    Distributed nationwide