FDAFDA recall Z-2821-2026 · Aug 5, 2026
Instrumentation Laboratory: GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM recall
Recall found
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
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924 Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- Quantity
- 122
- Distribution
- US Nationwide distribution.
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-08
Source: openFDA enforcement record Z-2821-2026 · search recall number Z-2821-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.