Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
Check GEM Premier 5000 cartridge lot numbers
Certain GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may eject repeatedly during startup due to detection errors. This can cause delays in test results and require staff to replace cartridges multiple times. The issue affects specific lot numbers manufactured between October and December 2025.
- Check if your GEM Premier 5000 uses cartridges from the affected lot numbers (251021K through 251231G)
- Contact Instrumentation Laboratory if you have affected cartridges to discuss options
- Plan for potential delays in test turnaround times and have backup cartridges available
- Continue using cartridges that pass the AutoPAK Validation check after startup
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-1539-2026More 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 increased detection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for increased error rate
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