Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
Check GEM Premier 5000 cartridge performance
Instrumentation Laboratory GEM PAK cartridges (part number 00055445008) for the GEM Premier 5000 blood gas analyzer may eject repeatedly during warm-up due to detection errors. This can delay test results and require operator intervention to restart testing. The issue affects 70 units distributed worldwide.
- If your facility uses the GEM Premier 5000 with affected cartridges, monitor for repeated cartridge ejections during warm-up
- Contact Instrumentation Laboratory for guidance on affected lot numbers (251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, 251215K)
- Plan for potential operational delays and have backup cartridges available
- Document any recurring ejection issues and report to your device support team
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2026More Instrumentation Laboratory recalls
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for detection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 cartridges may eject repeatedly during startup
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 cartridges recalled for increased detection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
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