The Recall Desk

Hazard

Inaccurate Diagnostic Results recalls

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

What the numbers show

Total
31
Critical
0
Severe
0
Most recent
2026-05-06

Of the 31 inaccurate diagnostic results 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 inaccurate diagnostic results 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.

26–31 of 31

  • HighFDA (Devices)·Z-0148-2015·2014-11-05

    Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias

    Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.

    Product
    siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2245-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems prov
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1151-2013·2013-04-24

    Siemens Vista Drug 4 Calibrator Recalled for Low Bias

    Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.

    Product
    Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0633-2013·2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0194-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.

    Product
    Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide