Hazard

Incorrect Results recalls

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

What the numbers show

Total: 88
Critical: 4
Severe: 2
Most recent: 2026-01-21

Of the 88 incorrect results recalls we have scored against our rubric, 4 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) 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 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.

76–88 of 88

ModerateFDA (Devices)·Z-0985-2014·2014-02-26
Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer
Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.
Product
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2280-2013·2013-10-02
Horiba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results
Horiba Medical is recalling ABX PENTRA Calcium CP Reagent because it may report incorrect calcium results on PENTRA 200 and 400 analyzers.
Product
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2051-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Product
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2048-2013·2013-09-04
Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.
Product
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2052-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Product
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2050-2013·2013-09-04
Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions
Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2049-2013·2013-09-04
Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.
Product
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2013·2013-05-29
Roche Cobas 8000 Software Recall for Incorrect Immunoassay Results
Roche Diagnostics is recalling software for the cobas e 602 module because it may produce incorrect test results under specific conditions.
Product
Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0801-2013·2013-02-20
Remel Lyophilized Growth Supplement Recalled for Microbial Contamination
Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.
Product
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0021-2013·2012-10-17
Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers
Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test results.
Product
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2012·2012-08-15
Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results
Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.
Product
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2012·2012-08-15
Abbott i-STAT PT/INR Cartridges Recalled for Incorrectly Elevated Results
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated results, potentially affecting monitoring of patients on anticoagulation therapy.
Product
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Category
Medical Device
Distribution
Distributed nationwide