The Recall Desk

Hazard

Inaccurate Results recalls

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

What the numbers show

Total
469
Critical
0
Severe
6
Most recent
2026-09-02

Of the 469 inaccurate 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 6 (1%) 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 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.

401–425 of 469

  • ModerateFDA (Devices)·Z-0795-2014·2014-01-29

    Remel Recalls Oxoid Ertapenem Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Ertapenem 10 mcg. Antimicrobial Susceptibility Test Discs because some cartridges may contain discs not impregnated with antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0732-2014·2014-01-22

    Vital Diagnostics Envoy Calcium Reagent Recalled for High Positive Bias

    Vital Diagnostics is recalling Envoy Calcium Reagent (PN 55285) due to high positive calcium bias in plasma samples compared to serum results.

    Product
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2014·2014-01-01

    Siemens Dimension Chemistry Wash Recalled for Result Shifts

    Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.

    Product
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2014·2013-12-25

    Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues

    Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.

    Product
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2014·2013-12-25

    Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.

    Product
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determinat
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid i
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0549-2014·2013-12-25

    Qualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for u
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended str
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0451-2014·2013-12-11

    Abbott i-STAT PT/INR Cartridges Recalled for Potential INR Errors

    Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated INR results.

    Product
    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0430-2014·2013-12-11

    Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error

    Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.

    Product
    Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0365-2014·2013-11-27

    Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift

    Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.

    Product
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of dir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2014·2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2014·2013-11-13

    SEPPIM Recalls Calcium Arsenazo Reagent Due to Inaccurate Plasma Results

    SEPPIM SAS is recalling Calcium Arsenazo reagent kits because plasma specimens may report higher calcium results than serum.

    Product
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantita
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0136-2014·2013-11-13

    Bayer A1CNow+ Test Kits Recalled for Potential Inaccurate Results

    Bayer is recalling A1CNow+ test kits because they may produce high-bias readings if stored at room temperature for 4 to 5 months.

    Product
    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2013·2013-10-09

    Radiometer Lactate Membrane Units Recalled for Enzyme Residue

    Radiometer America Inc. is recalling Lactate Membrane units for the E7077 Electrode due to potential enzyme residue that may cause inaccurate test results.

    Product
    Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue

    Instrumentation Laboratory is recalling 662 ACL TOP 300 and ACL TOP 300 CTS analyzers worldwide due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2248-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue

    Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2244-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems p
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2247-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can cause shortened APTT clotting times.

    Product
    ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2246-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems prov
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2170-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2172-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 44 units of ADVIA Centaur Folate reagent due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2190-2013·2013-09-18

    HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2047-2013·2013-09-04

    Siemens PSA Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.

    Product
    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 5
    Category
    Medical Device
    Distribution
    Distributed nationwide