Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000… — Class II medical device recall Z-2824-2026
Ongoing recall by Instrumentation Laboratory, reported 2026-08-05, distributed nationwide. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to ass
| Recall number | Z-2824-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-07-29 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 67 |
| UPC / GTIN / UDI-DI | 08426950869634, 08426950870227 |
| Serial numbers | 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516, 22082271, 23101109, 24011137, 25069638, 25081797, 25081799, 25091839, 25091840, 25091864, 25091868, 25091870, 25091873, 25091876 and 42 more |
| Model numbers | 00024015859, 00024019255 |
Product
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2824-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.