GEM Premier 5000 with IQM2 Model/Catalog Number recall
Instrumentation Laboratory recalled GEM Premier 5000 with IQM2 Model/Catalog Number on August 5, 2026 because of potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. It was sold nationwide.
Why it was recalled
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
What's recalled
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
Quantity: 122
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Instrumentation Laboratory, Bedford, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution. - Status
- Ongoing
- Recall number
- Z-2821-2026
- Source
- U.S. Food and Drug Administration
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