Hazard

Test Error recalls

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

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2024-09-25

Of the 11 test error 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 test error 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.

1–11 of 11

HighFDA (Devices)·Z-3180-2024·2024-09-25
Beckman Coulter Analyzer Recalled for Pneumatic Tubing Defects
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2022·2022-06-08
Medical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect
Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.
Product
DYNEX Agility, Agility Analyzer, Model No. 67000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1075-2019·2019-04-10
Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues
Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0393-2018·2018-01-31
BD MAX UVE Specimen Collection Kit Recalled for Test Result Issues
Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-testing.
Product
BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2770-2017·2017-08-02
Biomerieux Recalls VITEK 2 Gram Negative Test Kits Due to Errors
Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.
Product
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1720-2016·2016-06-01
Accriva APTT Cuvettes Recalled Due to Mis-positioned Reagent
Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high results.
Product
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2168-2014·2014-08-20
Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates
Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.
Product
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of tox
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2088-2014·2014-07-30
ITC-Nexus Dx Recalls Hemochron Jr. APTT Cuvettes Due to Test Errors
ITC-Nexus Dx is recalling Hemochron Jr. APTT cuvettes because they may produce erroneously elevated test results or out-of-range high error codes in non-heparinized blood samples.
Product
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1584-2013·2013-07-03
Roche Recalls CoaguChek XS Meters Due to Potential Test Errors
Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2013·2013-07-03
Roche Recalls CoaguChek XS Pro Systems Due to Potential Test Errors
Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.
Product
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2013·2013-07-03
Roche Recalls CoaguChek XS Plus Systems Due to Potential Test Errors
Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Category
Medical Device
Distribution
Distributed nationwide