The Recall Desk

Hazard

False Result recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-06-17

Of the 6 false 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 false 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.

1–6 of 6

  • HighFDA (Devices)·Z-2398-2026·2026-06-17

    Siemens Dimension tacrolimus reagent cartridges may bias results positively

    Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.

    Product
    Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2026·2026-06-17

    EXENT Analyser marked plates as passed without performing quality control

    An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.

    Product
    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2021·2021-09-22

    Roche cobas infinity software may release incorrect test results to laboratories

    Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.

    Product
    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2020·2020-02-26

    Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.

    Product
    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2020·2020-02-26

    Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.

    Product
    Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagno
    Category
    Medical Device
    Distribution
    Distributed nationwide