Hazard

Inaccurate Diagnostic Result recalls

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

What the numbers show

Total: 24
Critical: 0
Severe: 0
Most recent: 2020-10-28

Of the 24 inaccurate diagnostic result 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 inaccurate diagnostic result 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.

1–24 of 24

HighFDA (Devices)·Z-0134-2021·2020-10-28
Siemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
Siemens Healthcare Diagnostics is recalling Alkaline Phosphatase (ALPI) Flex reagent cartridges due to low outlier test results. The recall covers 5,970 US units and 1,446 international units.
Product
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1469-2020·2020-03-18
Binding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits
The Binding Site Group is recalling 462 VaccZyme assay kits due to performance deterioration that may cause falsely elevated antibody results.
Product
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2019·2019-09-18
Instrumentation Laboratory Recalls ROTEM ex-tem Kits Due to Prolonged Clotting Times
Instrumentation Laboratory is recalling 364 ROTEM ex-tem kits because they may produce prolonged clotting times. The recall affects specific lots distributed in the US and internationally.
Product
ROTEM ex-tem; US Part No: 503-05-US
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1950-2019·2019-07-17
Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.
Product
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0971-2019·2019-03-13
Abbott Recalls Architect Magnesium Assay Due to Depressed Urine Results
Abbott is recalling Architect Magnesium assays because urine tests may show falsely low results. The recall covers 24,995 units distributed in the US and four other countries.
Product
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2931-2018·2018-09-05
CSL Behring Recalls N Latex CDT Kits Due to Measurement Bias
CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.
Product
N Latex CDT Kit
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1067-2018·2018-03-21
Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.
Product
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0827-2018·2018-03-07
Siemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.
Product
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative de
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0290-2018·2018-01-03
Remel Shigella sonnei Agglutinating Serum Recalled for Failure to Agglutinate
Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.
Product
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0884-2017·2016-12-28
Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.
Product
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2704-2016·2016-09-07
Siemens ADVIA Chemistry XPT Recall for A1c Calculation Error
Siemens is recalling ADVIA Chemistry XPT systems due to a software error that causes falsely low Hemoglobin A1c results in IFCC units.
Product
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2360-2016·2016-08-31
Alere INRatio2 PT/INR Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.
Product
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with re
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2354-2016·2016-08-31
Alere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.
Product
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2355-2016·2016-08-31
Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.
Product
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2016·2016-03-09
Siemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall
Siemens Healthcare Diagnostics is recalling Dimension Vista B2 Microglobulin reagent cartridges due to increased abnormal assay errors and calibration failures that may produce inaccurate patient results.
Product
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinize
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0630-2016·2016-01-27
Arkray SPOTCHEM II Glucose Reagent Test Strips Recalled for Inaccurate Results
Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.
Product
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0159-2016·2015-11-04
LifeHealth Recalls IRMA TRUPOINT Blood Gas Analyzer CC Cartridges
LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.
Product
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0880-2015·2015-01-14
Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system may provide INR results significantly lower than reference laboratory methods.
Product
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0930-2014·2014-02-12
Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.
Product
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2013·2013-08-21
Epocal BGEM Test Card Recall for Potential Glucose Measurement Errors
Epocal is recalling 828,750 BGEM Test Cards because the glucose sensor may report low results at high concentrations after 3-4 months of storage.
Product
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1924-2013·2013-08-14
Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.
Product
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0957-2013·2013-03-27
Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery
Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.
Product
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0837-2013·2013-02-27
International Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results
International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes because they may produce lower than expected Prothrombin Time/INR results.
Product
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin ti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2013·2013-01-09
Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent
Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.
Product
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Category
Medical Device
Distribution
Distributed nationwide