Instrumentation Laboratory GEM Premier 5000 cartridges recalled for repeated ejection errors
Check your GEM Premier 5000 cartridge performance
Instrumentation Laboratory has identified that GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality checks during startup, causing the cartridge to eject. This can happen multiple times in a row, which delays test results. The cartridges that pass quality checks after startup can continue to be used.
- Contact Instrumentation Laboratory if your GEM Premier 5000 is experiencing repeated cartridge ejections during warm-up
- Plan for extra cartridges on hand to minimize testing delays
- Verify that cartridges pass the AutoPAK Validation quality check before use
- Notify your lab team about potential delays to patient result reporting
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-1536-2026More 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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