GEM Premier 3000 PAK — Class II medical device recall Z-0359-2024
Ongoing recall by Instrumentation Laboratory, reported 2023-11-29, distributed in MA, MN, NY. Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positiv
| Recall number | Z-0359-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2023-09-29 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Distributed | MA, MN, NY |
| Countries outside the US | IN |
| Quantity | 2,448 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08426950082491, 08426950082521, 08426950082552, 08426950082576 |
| Lot numbers | 323042E, 323042G, 323042K, 323052E, 323052G, 323062K, 323072J, 323072K, 323142A, 323142D, 323152A, 323152B, 323162A, 323162C, 323342H, 323342K, 323352G, 323352H, 323352I, 323352K, 323362F, 323442F, 323442H, 323462C, 323462F, 323542A, 323542E, 323552A, 323552F, 323552I, 323562F, 323562I, 323572A, 323652I, 323662D, 323662I, 323672I, 323742C, 323752B, 323762D and 34 more |
| Model numbers | 00024315009, 00024330009, 00024345009, 00024360009 |
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Reason for recall
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
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-0359-2024. 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.