Hazard

Inaccurate Test Result recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2026-07-22

Of the 9 inaccurate test 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 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 test 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.

1–9 of 9

ModerateFDA (Devices)·Z-2746-2026·2026-07-22
Tosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
Tosoh Bioscience is recalling ST AIA-Pack Testosterone test kits due to low-quality control results that could produce falsely elevated or falsely low testosterone measurements, potentially leading to unnecessary testing or delayed diagnosis.
Product
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2025·2025-06-04
Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.
Product
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0054-2024·2023-11-01
FDA Recalls Multiple Unauthorized Diagnostic Test Products by Universal Meditech
Universal Meditech Inc. is recalling diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.
Product
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1575-2023·2023-05-17
STA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results
Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.
Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1540-2020·2020-04-01
Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference
Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high results for patients taking eltrombopag.
Product
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2019·2018-11-14
Roche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results
Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR results.
Product
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2390-2018·2018-07-18
Roche Vitamin D Test System Recalled for Falsely Elevated Results
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Product
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D su
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2013·2013-07-03
Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors
Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2013·2013-01-16
Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors
Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.
Product
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, biliru
Category
Medical Device
Distribution
Distributed nationwide