Hazard

Reagent Carryover recalls

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

What the numbers show

Total: 22
Critical: 0
Severe: 0
Most recent: 2023-09-06

Of the 22 reagent carryover 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 reagent carryover 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.

1–22 of 22

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-2471-2023·2023-09-06
Laboratory diagnostic test may produce inaccurate results from reagent carryover
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
Product
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2023·2023-09-06
Atellica CH Triglycerides Diagnostic Kit Recalled for Reagent Carryover
Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.
Product
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2473-2023·2023-09-06
Diagnostic reagent kit recall: potential test result inaccuracy
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
Product
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2472-2023·2023-09-06
Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue
Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.
Product
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2023·2023-09-06
Atellica CH Triglycerides_2 Reagent Recalled Due to Magnesium Test Interference
Siemens Healthcare Diagnostics is recalling 5,315 units of Atellica CH Triglycerides_2 diagnostic reagent due to reagent carryover that can affect magnesium test results. The product was distributed nationwide and internationally.
Product
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1268-2023·2023-09-06
Siemens Atellica CH Analyzer: Reagent Carryover Affecting Magnesium Test Results
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
Product
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1269-2023·2023-09-06
Siemens Atellica CH Total Protein II Recalled for Reagent Carryover
Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.
Product
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2023·2023-08-30
ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
Product
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1498-2022·2022-08-10
Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover
Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.
Product
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0929-2022·2022-04-20
Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2022·2022-04-20
Siemens Atellica CH Calcium_2 Reagent Carryover Recall
Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.
Product
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2022·2022-04-20
Siemens Atellica CH Lithium reagent recalled for potential reagent carryover
Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.
Product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0930-2022·2022-04-20
Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Product
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2022·2021-11-03
Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2022·2021-11-03
Siemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2963-2020·2020-09-23
Randox Lactate Dehydrogenase Reagent Recall for Carryover Avoidance
Randox Laboratories is recalling Lactate Dehydrogenase P-L reagent to address reagent carryover issues on RX instruments that may cause erroneous test results.
Product
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX dayt
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2962-2020·2020-09-23
Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps
Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.
Product
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2754-2019·2019-10-02
Siemens Recalls Atellica IM Anti-CCP IgG Assay Due to Mitigation Failure
Siemens Healthcare Diagnostics is recalling 169 kits of the Atellica IM anti-CCP IgG assay because a reagent carryover mitigation step fails to complete on the analyzer.
Product
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0840-2019·2019-02-27
Randox Calcium Reagent Recall for Potential Carryover Errors
Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover. This issue may cause falsely elevated or decreased results in patient and QC samples.
Product
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0798-2019·2019-02-13
Abbott Recalls Free T3 Reagent Kits Due to Carryover Issues
Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
Product
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0799-2019·2019-02-13
Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover
Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
Product
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide