Hazard

False Test Results recalls

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

What the numbers show

Total: 14
Critical: 0
Severe: 2
Most recent: 2026-08-12

Of the 14 false 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 2 (14%) 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 false 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.

1–14 of 14

SevereFDA (Devices)·Z-2889-2026·2026-08-12
Beckman Coulter MicroScan Panel Update DVD Kits Recalled
Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.
Product
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan Walk
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2890-2026·2026-08-12
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1504-2025·2025-04-09
Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results
Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.
Product
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0673-2025·2024-12-18
Medical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results
Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.
Product
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2474-2023·2023-09-06
Siemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
Siemens has recalled 18,524 units of its Atellica CH HDL Cholesterol diagnostic device due to potential reagent carryover that could produce false test results in patient samples and quality control testing.
Product
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1683-2023·2023-06-14
QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2022·2022-08-03
Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results
Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.
Product
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0735-2022·2022-03-16
Laboratory diagnostic tips recalled for potential dispensing errors
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Product
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2304-2019·2019-08-28
BD Vacutainer Blood Collection Tubes Recalled for False COHb Results
Becton Dickinson is recalling specific blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2018·2018-03-14
Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results
Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.
Product
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratorie
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2351-2016·2016-08-17
Richard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination
Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin due to potential potassium hydroxide contamination that may affect immunohistochemistry test results.
Product
Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1925-2015·2015-07-08
Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.
Product
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide