The Recall Desk

Manufacturer

Instrumentation Laboratory

46 recalls in our database name Instrumentation Laboratory as the manufacturing or recalling firm.

What the numbers show

Total
46
Critical
0
Severe
1
Most recent
2026-08-12

Of the 46 recalls from Instrumentation Laboratory we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 46

  • SevereFDA (Devices)·Z-2900-2026·2026-08-12

    GEM Premier 5000 PAK Lysing Solution Concentration Recall

    Specific lots of the GEM Premier 5000 PAK lysing bag solution have an active ingredient concentration that does not meet manufacturing specifications, which could delay recognition and management of Co-Oximetry and total bilirubin abnormalities.

    Product
    GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2899-2026·2026-08-12

    GEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues

    Instrumentation Laboratory is recalling specific GEM Premier 7000 with iQM3 PAK lots because the lysing bag solution concentration does not meet manufacturing specifications, potentially delaying medical management.

    Product
    GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2822-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2826-2026·2026-08-05

    Blood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID

    Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2026·2026-08-05

    Portable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk

    Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
    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-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-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-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-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
  • 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

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

INSTRUMENTATION LABORATORY COMPANY

Source: Wikidata (Q138457451), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.