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FDA recall, , Moderate risk

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier 5000 and 7000 systems with BCR wands may assign results to wrong patient.

Summary by Recall Canary from the FDA notice

What happened

Instrumentation Laboratory of Bedford, Massachusetts, recalled GEM Premier 5000 and GEM Premier 7000 portable blood analyzer systems with Bar Code Reader (BCR) wands because the wands may assign patient results to an incorrect patient ID. The BCR wands received a configuration update released under Service Information No. 2026-07 on or after April 8, 2026. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw.

The recall, begun May 8, 2026, covers US Nationwide distribution. Affected products include the GEM Premier 5000 with IQM2 and the GEM Premier 7000 with iQM3, both using the BCR Wand Part No. 00024015859. The FDA added the recall to its Enforcement Report on July 29, 2026.

More device defect recalls

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What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. GEM Premier 5000 with IQM2 Model/

    Product details from the notice

    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

    UDI-DI
    • 00024019255
    • 08426950870227
    • 00000015279
    • 0195226000924
    • 00024015859
    • 08426950869634

  2. GEM Premier 5000

    1. UDI-DI
      • 00024019255
      • 08426950870227
      • 25028719
      • 18021546
      • 18021549
      • 26012036
      • 18051850
      • 23054764
      • 21068342
      • 25080219
      • 26010781
      • 25122012
      • 25041639
      • 25120558
      • 25079944
      • 25079943
      • 25100485
      • 25079947
      • 25100483
      • 25100484
      • 21057870
      • 26010710
      • 00024015859
      • 08426950869634
      Model/Catalog number
      00024019255 Portable blood analyzer system
    2. UDI-DI
      • 00024019255
      • 08426950870227
      • 20106073
      • 20106039
      • 19052933
      • 20116415
      • 20064792
      • 22062065
      • 22062067
      • 19103490
      • 22092716
      • 22102881
      • 18112339
      • 19012518
      • 20126582
      • 20075256
      • 20064794
      • 20106036
      • 24016057
      • 21088758
      • 21088759
      • 18061910
      • 24016081
      • 24016108
      • 24108036
      • 24108044
      • 24067370
      • 24067371
      • 24077468
      • 00024015859
      • 08426950869634
      Model/Catalog number
      00024019255 portable blood analyzer system
    3. UDI-DI
      • 00024019255
      • 08426950870227
      • 25110547
      • 25100462
      • 25110522
      • 25100472
      • 25101897
      • 25101920
      • 25101931
      • 25122029
      • 26012032
      • 25122030
      • 26012033
      • 26012043
      • 25110523
      • 25110536
      • 25120550
      • 25069638
      • 23101109
      • 24011137
      • 25081799
      • 25081797
      • 25091839
      • 25091840
      • 25091864
      • 25091870
      • 25091868
      • 25091873
      • 25091880
      • 25091876
      • 25101886
      • 25101889
      • 25101887
      • 25101891
      • 25101907
      • 25101904
      • 25101912
      • 25101905
      • 25101917
      • 25101921
      • 25101926
      • 25101929
      • 25101934
      • 25101927
      • 25111968
      • 25121986
      • 25121985
      • 25121981
      • 25121984
      • 25121994
      • 25121995
      • 25121982
      • 25121993
      • 25121991
      • 25121999
      • 25121996
      • 16030255
      • 17060782
      • 17060784
      • 17060785
      • 17060789
      • 17060790
      • 17060797
      • 17111126
      • 17121258
      • 18011414
      • 20054515
      • 20054516
      • 22082271
      • 00024015859
      • 08426950869634
      Model/Catalog number
      00024019255 portable blood analyzer system
    4. UDI-DI
      • 00024019255
      • 08426950870227
      • 25100466
      • 24097933
      • 23064897
      • 00024015859
      • 08426950869634
      Model/Catalog number
      00024019255 Portable blood analyzer system

  3. GEM Premier 7000 with iQM3

    UDI-DI
    • 00000015279
    • 0195226000924
    • 26012062
    • 26012065
    • 26012069
    • 26012070
    • 00024015859
    • 08426950869634
    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

Recall details

Company began the recall
Sold in

US Nationwide distribution.

Company
Instrumentation LaboratoryBedford, Massachusetts
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99115
Recall numbers
Z-2821-2026 to Z-2826-2026

All recalls from Instrumentation Laboratory

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

More from this company

Summary by Recall Canary, written with AI · summary updated Oct 10, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)