GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011… — Class II medical device recall Z-2900-2026
Ongoing recall by Instrumentation Laboratory, reported 2026-08-12, distributed nationwide. The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet
| Recall number | Z-2900-2026 |
|---|---|
| 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 | 109 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08426950807537, 08426950807599, 08426950807605, 08426950807698, 08426950807759, 08426950807766, 08426950807810, 08426950807827 |
| Lot numbers | 260504AA, 260504AF, 260504AG, 260505F, 260505H, 260505J, 260505K, 260505R |
| Model numbers | 00055360010, 00055360010.A, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, 00055445010, 00055445011 |
Product
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Reason for recall
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 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-2900-2026. 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.