[Recalled] GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 — Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit… | FDA 2023-0
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 |
|---|---|
| Brand / manufacturer | Instrumentation Laboratory |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0358-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 29 September 2023 |
| EAN / barcode | 00024307507 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.