Instrumentation Laboratory GEM Premier 5000 cartridges recalled for increased ejection errors
Contact Instrumentation Laboratory about GEM Premier 5000 cartridges
Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing increased errors during warm-up that cause them to eject unexpectedly. This can require repeated cartridge replacements and may delay test results. Most cartridges continue to work normally, but consecutive ejections could disrupt lab operations.
- If you operate a GEM Premier 5000, check if your cartridge lot number matches the recall list
- Contact Instrumentation Laboratory for specific guidance on your affected cartridges
- Ensure your iQM2 quality control monitoring is active to catch any issues
- Plan ahead to minimize operational delays if cartridge ejections occur
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-1535-2026More 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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