The Recall Desk

Hazard

Incorrect Diagnostic Result recalls

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

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2019-04-03

Of the 6 incorrect diagnostic result recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) 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 incorrect diagnostic result 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.

1–6 of 6

  • HighFDA (Devices)·Z-1065-2019·2019-04-03

    Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results

    Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.

    Product
    Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse da
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2019·2018-10-24

    Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.

    Product
    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2599-2018·2018-08-08

    Beckman Coulter MicroScan Pos Combo Panel Type 43 Recalled for Incorrect Moxifloxacin Dilution

    Beckman Coulter is recalling MicroScan Pos Combo Panel Type 43 because an incorrect Moxifloxacin dilution sequence may cause inaccurate antimicrobial susceptibility results.

    Product
    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2880-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2012·2012-08-29

    Abbott i-STAT cTnI Cartridges Recalled for Incorrectly Elevated Troponin Results

    Abbott Point of Care is recalling i-STAT cTnI cartridges because they may produce incorrectly elevated cardiac troponin I results.

    Product
    i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatmen
    Category
    Medical Device
    Distribution
    Distributed nationwide