The Recall Desk

Hazard

Test Interference recalls

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

What the numbers show

Total
57
Critical
0
Severe
0
Most recent
2024-04-24

Of the 57 test interference 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 test interference 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.

26–50 of 57

  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

    Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2018·2018-06-13

    Tosoh FSH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2018·2018-06-13

    Tosoh ST-AIA PACK LH II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK LH II assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2018·2018-06-13

    Tosoh AIA-PACK TSH 3rd Generation Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2018·2018-06-13

    Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2018·2018-06-13

    Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2018·2018-06-13

    Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2018·2018-06-13

    Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.

    Product
    ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2018·2018-06-13

    Tosoh ST-AIA PACK T4 Thyroid Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2018·2018-06-13

    Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1670-2018·2018-05-16

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.

    Product
    Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.

    Product
    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2018·2018-05-16

    Siemens Recalls Dimension Vista MMB Reagent Cartridges Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.

    Product
    Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1748-2017·2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, AD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1747-2017·2017-04-12

    Siemens ADVIA Centaur BR Assay Recalled for Potential Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR assays due to potential interference from the Syphilis assay on the same systems.

    Product
    Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2016·2016-05-18

    Siemens Recalls Direct HDL Cholesterol Assay Due to Interference

    Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.

    Product
    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2016·2016-05-18

    Siemens ADVIA Chemistry Enzymatic Creatinine 2 Recalled for Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY ENZYMATIC CREATININE_2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2016·2016-05-18

    Siemens Uric Acid Assay Recalled Due to Interference

    Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.

    Product
    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2016·2016-03-30

    Siemens Dimension Vista Estradiol Test Recalled Due to Interference

    Siemens is recalling Dimension Vista Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2016·2016-02-10

    Horiba ABX PENTRA Uric Acid CP Recalled for Interference

    Horiba Instruments Inc is recalling ABX PENTRA Uric Acid CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder
    Category
    Medical Device
    Distribution
    29 states