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.

226–250 of 469

  • ModerateFDA (Devices)·Z-1649-2018·2018-05-16

    Siemens Dimension Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1647-2018·2018-05-16

    Siemens ALT Assay Reagents Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.

    Product
    ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Pa
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1658-2018·2018-05-16

    Siemens Dimension Vista Glucose Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1660-2018·2018-05-16

    Siemens Dimension Vista Thyroxine Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.

    Product
    Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1540-2018·2018-05-09

    Siemens Dimension Vista Calcium Flex Reagent Cartridge Recalled for Low Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium Flex reagent cartridges because they may produce erroneously low results from specific well sets.

    Product
    Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1543-2018·2018-05-09

    PTS CHOL+GLU Test Strips Recalled for Potential Loss of Glucose Activity

    Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips due to a potential loss of glucose analyte activity before the stated shelf life.

    Product
    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1486-2018·2018-05-02

    Siemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 125II Assay kits because some patient samples may exhibit over-recovery outside the provided data.

    Product
    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1311-2018·2018-04-11

    Roche Recalls Elecsys BRAHMS PCT Immunoassay Due to Decreased Sample Recovery

    Roche Diagnostics is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay because it shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers.

    Product
    Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1301-2018·2018-04-11

    Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled for Performance Defect

    The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.

    Product
    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglo
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1267-2018·2018-04-04

    Medica EasyCAL HbA1c Calibrator Recalled for Potential Result Deviations

    Medica Corporation is recalling EasyCAL HbA1c Calibrator kits because patient results may deviate up to 20 percent.

    Product
    EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1268-2018·2018-04-04

    Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.

    Product
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1270-2018·2018-04-04

    Roche cobas e 411 Analyzer Recall for Questionable Results

    Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.

    Product
    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2018·2018-04-04

    Roche Modular E 170 Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.

    Product
    Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0895-2018·2018-03-14

    Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues

    Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0912-2018·2018-03-14

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DAT Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DAT Performance Verifier II because storage labeling errors may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0913-2018·2018-03-14

    Ortho-Clinical Recalls VITROS DAT Performance Verifier III Due to Labeling Error

    Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0915-2018·2018-03-14

    Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues

    Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2018·2018-03-07

    Tosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits

    Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.

    Product
    ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-0515-2018·2018-02-14

    Siemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias

    Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.

    Product
    ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0273-2018·2018-01-03

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.

    Product
    VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/95
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0174-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control Recalled for Inaccurate Ceruloplasmin Assignment

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall below the reference range.

    Product
    Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control M Recalled for Inaccurate Ceruloplasmin Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2018·2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0173-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results

    Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2018·2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Medical Device
    Distribution
    0 states