Hazard

Biased Results recalls

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

What the numbers show

Total: 10
Critical: 0
Severe: 2
Most recent: 2026-01-28

Of the 10 biased 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 2 (20%) 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 biased 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.

1–10 of 10

HighFDA (Devices)·Z-1135-2026·2026-01-28
LDL cholesterol assays recalled over triglyceride interference causing biased results
Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.
Product
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
Category
Medical Device
Distribution
52 states
LowFDA (Devices)·Z-0471-2021·2020-11-25
Ortho VITROS Chemistry Performance Verifier II Recalled for Product Instability
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Performance Verifier II due to product instability that causes biased ALKP values.
Product
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Syste
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1931-2020·2020-05-20
Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions
Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.
Product
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2019·2019-03-20
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.
Product
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-1887-2017·2017-05-03
Ortho VITROS VANC Reagent Recalled for Potential Biased Test Results
Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.
Product
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactur
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1743-2015·2015-06-17
Ortho-Clinical VITROS 5600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.
Product
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2015·2015-06-17
Ortho-Clinical VITROS 4600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.
Product
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2015·2014-12-31
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2014·2014-06-18
Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.
Product
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1736-2014·2014-06-18
Ortho-Clinical VITROS 5,1 FS Chemistry System Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.
Product
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide