The Recall Desk

Hazard

False Results recalls

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

What the numbers show

Total
35
Critical
0
Severe
0
Most recent
2026-02-11

Of the 35 false 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 false 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.

26–35 of 35

  • ModerateFDA (Devices)·Z-2068-2018·2018-06-13

    Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2018·2017-12-27

    BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures

    BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.

    Product
    ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2018·2017-10-18

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2017·2017-05-24

    Beckman Coulter Recalls Triglycerides Reagent Due to Interference

    Beckman Coulter is recalling Triglycerides Reagent because specific drugs can cause false low results.

    Product
    Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2080-2017·2017-05-24

    Beckman Coulter Recalls Enzymatic Creatinine Reagent Due to Interference

    Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.

    Product
    Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1226-2017·2017-03-01

    BioMerieux ETEST XM256 Cefuroxime Recalled for Potential Performance Issues

    BioMerieux SA is recalling ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips due to potential performance issues that may result in false susceptibility or intermediate results.

    Product
    ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus sp
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-1958-2014·2014-07-09

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is correcting labeling for 614 Simplexa Flu A/B & RSV Direct kits due to sporadic false signals that may increase false results.

    Product
    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2014·2014-06-25

    Roche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues

    Roche Diagnostics is recalling cobas 8000 analyzer filters that may cause discrepant results, alarms, or foam under certain conditions.

    Product
    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0976-2013·2013-04-03

    Becton Dickinson Recalls BD MAX PCR Cartridges Due to Sealing Defects

    Becton Dickinson & Co. is recalling BD MAX PCR Cartridges because they may not seal properly, potentially causing false or invalid test results.

    Product
    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detecti
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0003-2013·2012-10-10

    Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results

    Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.

    Product
    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations i
    Category
    Medical Device
    Distribution
    Distributed nationwide