Hazard

Assay Interference recalls

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

What the numbers show

Total: 19
Critical: 0
Severe: 0
Most recent: 2026-01-28

Of the 19 assay interference 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 assay interference 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.

1–19 of 19

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
HighFDA (Devices)·Z-0997-2026·2025-12-31
Bicarbonate reagent recalled over falsely high results from LDH interference
Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.
Product
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2025·2025-08-13
UIBC assay does not meet its labeled hemoglobin interference claim
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
Product
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2152-2025·2025-07-30
Estrone RIA kits give falsely increased results from a bovine albumin lot
Estrone RIA kits are being recalled because a specific lot of bovine serum albumin used to manufacture the coated tubes caused falsely increased assay results. 496 units are affected.
Product
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-3006-2020·2020-09-30
Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference
Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.
Product
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2020·2020-06-17
Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference
Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.
Product
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2020·2020-03-11
Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0210-2020·2019-10-30
Beckman Coulter Lipase Recalled Due to Acetaminophen Interference
Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.
Product
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0211-2020·2019-10-30
Beckman Coulter Uric Acid Assay Recalled Due to Interference
Beckman Coulter is recalling Uric Acid assays because acetaminophen metabolites cause negative interference in overdose patients.
Product
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2018·2018-06-13
Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK Testosterone assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.
Product
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1749-2017·2017-04-12
Siemens ADVIA Centaur BR Assay Recalled for Potential Syphilis Assay Interference
Siemens is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay, which may affect test accuracy.
Product
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centau
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0402-2017·2016-11-23
Siemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference
Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.
Product
Dimension IRON Flex reagent cartridges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2017·2016-10-26
Ortho-Clinical VITROS Chemistry TRIG Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Product
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0090-2017·2016-10-26
Ortho-Clinical VITROS Chemistry LAC Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Product
VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0089-2017·2016-10-26
Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference
Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.
Product
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2416-2015·2015-08-26
Siemens ADVIA Chemistry Acetaminophen Reagents Recalled for NAC Interference
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Acetaminophen reagents due to a change in N-acetylcysteine concentration that may cause assay interference.
Product
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1653-2014·2014-06-04
Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.
Product
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1657-2014·2014-06-04
Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference
Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.
Product
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1659-2014·2014-06-04
Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference
Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.
Product
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Category
Medical Device
Distribution
Distributed nationwide