Hazard

Invalid Test Results recalls

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

What the numbers show

Total: 16
Critical: 0
Severe: 0
Most recent: 2025-04-23

Of the 16 invalid test 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 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 invalid test 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.

1–16 of 16

ModerateFDA (Devices)·Z-1573-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to the product instructions.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1575-2025·2025-04-23
ID NOW Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled
Abbott Diagnostics is recalling ID NOW Influenza A/B 2 24T test kits (Model 427-000) nationwide because affected lots have a higher occurrence of invalid test results than stated in the product instructions.
Product
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1576-2025·2025-04-23
ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates
Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.
Product
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1572-2025·2025-04-23
ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates
Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.
Product
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2025·2025-02-19
Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures
Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.
Product
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2025·2025-01-22
Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.
Product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-2531-2024·2024-08-14
Pulmonary Heart Valve Grafts Recalled Due to Invalid Test Results
Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.
Product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2532-2024·2024-08-14
FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
Product
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2023·2023-03-15
COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results
DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.
Product
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2022·2022-04-13
C-Peptide ELISA Kit Recalled Due to Defective Standards
DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.
Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0553-2022·2022-02-09
ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results
Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2200-2021·2021-08-11
Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation
Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.
Product
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2020·2020-06-17
Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure
Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.
Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2745-2018·2018-08-22
Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference
Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.
Product
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemog
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0028-2018·2017-10-25
Cepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results
Cepheid is recalling Xpert EV Assay kits because customers reported a higher than expected number of invalid test results.
Product
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individual
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1022-2013·2013-04-03
Genetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results
Genetic Testing Institute is recalling 386 lots of LIFECODES PF4 Enhanced assay kits because inconsistent values can lead to invalid test results.
Product
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Category
Medical Device
Distribution
Distributed nationwide