GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510… — Class II medical device recall Z-2899-2026
Ongoing recall by Instrumentation Laboratory, reported 2026-08-12, distributed nationwide. The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots
| Recall number | Z-2899-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-08-06 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, DE, IT |
| Quantity | 32 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00195226000641, 00195226000658, 00195226000665, 00195226000757, 00195226000764, 00195226000856 |
| Lot numbers | 260504E, 260505A, 260505B, 260505C |
| Model numbers | 00077407508, 00077407510, 00077415004, 00077415008, 00077415010, 00077430010 |
Product
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
Reason for recall
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
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-2899-2026. 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.