Hazard

Inaccurate Results recalls

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

What the numbers show

Total: 469
Critical: 0
Severe: 6
Most recent: 2026-09-02

Of the 469 inaccurate 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 6 (1%) 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 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.

451–469 of 469

ModerateFDA (Devices)·Z-0162-2013·2012-11-07
Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.
Product
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Cen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0047-2013·2012-10-17
Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
Product
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0046-2013·2012-10-17
Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
Product
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. Th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0016-2013·2012-10-17
Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues
Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.
Product
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2460-2012·2012-10-03
Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues
Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.
Product
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2390-2012·2012-09-26
Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors
Instrumentation Laboratory is recalling ACL TOP 700 LAS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Product
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2389-2012·2012-09-26
Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors
Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Product
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of throm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2391-2012·2012-09-26
Instrumentation Laboratory ACL TOP 500 CTS Analyzer Recalled for Fibrinogen Errors
Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Product
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2169-2012·2012-08-15
Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects
Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.
Product
i-Stat cTnl cartridges Abbott Point of Care Inc. 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 troponin I measurements can be used as an aid in the diagnosis a
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2133-2012·2012-08-08
Abbott i-Stat EG7 Cartridges Recalled for Inaccurate PCO2 Results
Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.
Product
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2012·2012-08-08
Perkin Elmer Genetic Screening Processor Recalled for Shaker Unit Contamination
Perkinelmer is recalling 78 Genetic Screening Processor units worldwide because shaker unit contamination causes decreased signal activity in neonatal screening assays.
Product
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2124-2012·2012-08-08
Iris Diagnostics Recalls Urine Chemistry Control Material Due to Inaccurate Results
Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.
Product
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) us
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.
Product
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2012·2012-07-25
Critical Diagnostics Recalls Presage ST2 Assay Kits Due to Inaccurate Results
Critical Diagnostics is recalling Presage ST2 Assay kits because they may produce inaccurate test results for patients with chronic heart failure.
Product
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage S
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1929-2012·2012-07-18
Alere Triage Cardiac Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1867-2012·2012-07-04
Siemens BCS Behring Coagulation System Recalled for Potential Test Errors
Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.
Product
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1903-2012·2012-07-04
Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips
Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.
Product
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1904-2012·2012-07-04
Abbott Recalls Architect CA 19-9 Reagent Kits Due to Result Shifts
Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR Reagent Kits because they are causing an upward shift in patient test results.
Product
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2012·2012-07-04
Sekisui Recalls 1,600 Acetaminophen Assay Kits Due to Reagent Discoloration
Sekisui Diagnostics is recalling 1,600 MULTIGENT Acetaminophen assay kits distributed in Illinois because discoloration of the enzyme reagent causes erratic test results.
Product
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Category
Medical Device
Distribution
1 state