The Recall Desk

Hazard

In Vitro Diagnostic recalls

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

What the numbers show

Total
30
Critical
0
Severe
0
Most recent
2026-06-17

Of the 30 in vitro diagnostic 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 in vitro diagnostic 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.

1–25 of 30

  • 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-1806-2026·2026-04-22

    Yeastone Broth recalled because it may report incorrect susceptibility results

    Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.

    Product
    Yeastone Broth, 11ML, 10/BOX YY3462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2026·2026-04-15

    MicroScan multidrug resistance test panels recalled over incorrect processing

    MicroScan Neg Multidrug Resistant MIC 1 panels are being recalled because of a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. Three boxes are affected.

    Product
    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agen
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1795-2026·2026-04-15

    Preeclampsia growth factor assay recalled over out-of-range quality control values

    B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.

    Product
    B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0501-2026·2025-11-19

    Positive control serum recalled over negative recovery of the HBsAg analyte

    Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    Product
    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0502-2026·2025-11-19

    Second control serum lot recalled over negative HBsAg analyte recovery

    Techno-Path is recalling 51 units of Multichem ID-B positive control serum from a second lot because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    Product
    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and ant
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2026·2025-11-05

    Cardiac control material recalled over vial to vial troponin variability

    Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

    Product
    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2026·2025-10-15

    FlexLab X system recalled over unevaluated blood sample integrity function

    Inpeco is recalling one FlexLab X system because the Sample Integrity Module's hemolysis, icterus and lipemia function has not been evaluated by the FDA.

    Product
    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0071-2026·2025-10-15

    Phosphorus reagent lots recalled because calibration may fail before expiration date

    Beckman Coulter is recalling 2,146 units of SYNCHRON Systems Phosphorus reagent because specific lots may fail calibration before the lot expiration date, delaying patient results.

    Product
    SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2560-2025·2025-09-24

    Lactate slides in 18-slide cartridges recalled over calibration failures delaying results

    VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.

    Product
    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2584-2025·2025-09-24

    Blood gas EG7+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.

    Product
    i-STAT EG7+ cartridge. List Number: 03P76-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2025·2025-09-24

    Blood gas EG6+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.

    Product
    i-STAT EG6+ cartridge. List Number: 03P77-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2559-2025·2025-09-24

    Lactate test slides recalled over calibration failures delaying patient results

    VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.

    Product
    Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2583-2025·2025-09-24

    Blood gas CG8+ cartridges recalled for lacking updated premarket clearance

    i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.

    Product
    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2582-2025·2025-09-24

    Blood gas cartridges recalled for lacking clearance covering updated measurement ranges

    i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.

    Product
    i-STAT CG4+ cartridge (white). List Number: 03P85-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2025·2025-09-17

    Urinary protein assay recalled over falsely depressed patient and calibration results

    Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2025·2025-09-17

    Dipstick strep A tests recalled over potential for false positive results

    QuickVue Dipstick Strep A Tests are recalled because the test has the potential for false positive results. 22,470 units are affected.

    Product
    QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2025·2025-09-03

    Anti-Xa test kits recalled over potential contamination by fibrinogen reagents

    STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.

    Product
    STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide