[Recalled] GEM Premier 5000; Part No. 00055415010. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM… | FDA 2026-01-20
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | GEM Premier 5000; Part No. 00055415010. |
|---|---|
| Brand / manufacturer | Instrumentation Laboratory |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1535-2026 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 January 2026 |
| EAN / barcode | 00055415010 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
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 →
Related recalls from Instrumentation Laboratory
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.