Instrumentation Laboratory GEM Premier 5000 cartridges recalled for repeated ejection errors
Check your GEM Premier 5000 cartridge performance
Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated "Process Control Solution Not Detected" errors during startup, causing the cartridges to be ejected and requiring replacement. This can delay test results. The affected cartridges are lot numbers 251114K, 251205K, and 251215D (Part No. 00055430011).
- If you operate a GEM Premier 5000, monitor cartridge performance during warm-up
- If a cartridge is repeatedly ejected, replace it with a new one
- Plan ahead for potential operational delays if multiple cartridges fail in sequence
- Contact Instrumentation Laboratory if you have questions about affected lot numbers
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-1540-2026More 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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