Hazard

Measurement Bias recalls

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

What the numbers show

Total: 39
Critical: 0
Severe: 0
Most recent: 2026-07-29

Of the 39 measurement bias 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 measurement bias 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.

26–39 of 39

HighFDA (Devices)·Z-1150-2023·2023-03-01
Siemens Atellica IM Folate 700 test kit recalled for measurement bias
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
Product
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2023·2023-03-01
Atellica IM Folate test kit recalled for measurement bias issues
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
Product
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1149-2023·2023-03-01
Siemens Atellica IM Folate 140 test kit recalled for measurement bias
Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.
Product
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2023·2023-01-11
VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.
Product
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0355-2023·2022-12-14
Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
Product
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2022·2022-07-13
ABL800 Flex Analyzer Recalled for Potential Measurement Bias
Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.
Product
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0236-2022·2021-11-24
Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues
Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.
Product
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1563-2021·2021-05-19
Randox Calibration Serum Level 3 Recalled for Bilirubin Bias
Randox Laboratories is recalling 98 kits of Calibration Serum Level 3 (CAL 3) due to a positive bias in bilirubin measurements.
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-1800-2020·2020-05-06
Bio-Rad Autoimmune EIA Anti-Tissue Transglutaminase IgA Test Recalled for Lot Bias
Bio-Rad Labs is recalling 376 units of the Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test, Lot 18200A, due to elevated lot-to-lot bias affecting antibody measurements.
Product
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0737-2020·2020-01-01
Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
Product
STA UNICALIBRATOR (ref. 00675)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-3185-2018·2018-09-26
Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage
Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.
Product
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0420-2015·2014-12-03
Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias
Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.
Product
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Meas
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1517-2014·2014-05-07
Siemens IMMULITE Total IgE Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.
Product
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0255-2013·2012-11-14
Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias
Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.
Product
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagn
Category
Medical Device
Distribution
Distributed nationwide