The Recall Desk

Hazard

Testing Delay recalls

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

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2025-09-24

Of the 8 testing delay 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 testing delay 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.

1–8 of 8

  • 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-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-2345-2025·2025-08-27

    ELISA sample tip racks recalled over internal label misidentifying tip type

    Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.

    Product
    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2335-2025·2025-08-27

    Calcium test slides recalled after calibration failures delayed patient results

    VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.

    Product
    VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2024·2024-05-08

    OsmoPRO MAX Clinical Osmometer Recall for Software Errors and Result Inaccuracy

    Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.

    Product
    OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1327-2020·2020-02-26

    Binding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues

    The Binding Site Group is recalling OPTILITE IgM Kits due to potential calibration difficulties that may cause false patient results and testing delays.

    Product
    OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
    Category
    Medical Device
    Distribution
    28 states
  • LowFDA (Devices)·Z-0601-2019·2018-12-19

    Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation

    Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.

    Product
    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide