The Recall Desk

Hazard

Result Delay recalls

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

What the numbers show

Total
33
Critical
0
Severe
0
Most recent
2026-07-15

Of the 33 result 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 result 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.

1–25 of 33

  • ModerateFDA (Devices)·Z-2713-2026·2026-07-15

    GSP Neonatal GALT Kit in vitro diagnostic test equipment

    WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.

    Product
    GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2026·2026-03-18

    GEM Premier 5000 parts 00055445010 and 00055445011 may eject cartridges

    Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Part No. 00055445010 & 00055445011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2026·2026-03-18

    GEM Premier 5000 part 00055415008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360008 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360004 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK, Part No. 00055360004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360011 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2026·2026-03-18

    GEM Premier 5000 cartridges may eject repeatedly during analyzer warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Model No. 00055430010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2026·2026-03-18

    GEM Premier 5000 part 00055415010 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360010 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407510 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407510.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2026·2026-03-18

    GEM Premier 5000 part 00055445004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055445004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407508 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407511 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407511.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2026·2026-03-18

    GEM Premier 5000 part 00055430011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407504 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407504 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407504.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2026·2026-03-18

    GEM Premier 5000 PAK part 00055415004 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055415004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055415004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2026·2026-03-18

    GEM Premier 5000 part 00055445008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055445008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    GEM Premier 5000 part 00055430004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2026·2026-03-18

    GEM Premier 5000 part 00055430008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2026·2026-03-18

    GEM Premier 5000 part 00055415011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000 part 00055415005 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2270-2025·2025-08-13

    DxI 600 immunoassay analyzer motor current resets below the required setting

    A DxI 600 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.

    Product
    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2268-2025·2025-08-13

    DxI 800 with Spot B analyzer motor current resets below requirement

    DxI 800 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 451 systems are affected.

    Product
    DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2269-2025·2025-08-13

    UniCel DxI 600 analyzer motor current resets below the required setting

    UniCel DxI 600 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 271 systems are affected.

    Product
    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
    Category
    Medical Device
    Distribution
    Distributed nationwide