Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000… — Class II medical device recall Z-2822-2026
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-2822-2026 |
|---|---|
| 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 | 4 us |
| UPC / GTIN / UDI-DI | 00195226000924, 08426950869634 |
| Serial numbers | 26012062, 26012065, 26012069, 26012070 |
| Model numbers | 00000015279, 00024015859 |
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
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-2822-2026. 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.