Instrumentation Laboratory GEM Premier 5000 cartridges recalled for cartridge ejection errors
Check your GEM Premier 5000 cartridge performance
Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer may reject during the warm-up process, requiring replacement cartridges to be inserted. This can delay test results and may require doctors to reassess patient care once results are available. The issue affects specific lot numbers distributed worldwide.
- If you operate a GEM Premier 5000, monitor cartridge performance during warm-up for repeated ejections
- Contact Instrumentation Laboratory if your cartridge is from one of the affected lots (251021P through 251229X)
- Plan ahead to minimize testing delays if cartridge ejection occurs
- Ensure the iQM2 quality control system completes validation before using a cartridge
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-1534-2026More 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 PAK cartridges recalled for increased error rate
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