Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for increased error rate
Check GEM Premier 5000 PAK cartridge performance
Instrumentation Laboratory has identified that some GEM PAK cartridges (part no. 00055407511) for the GEM Premier 5000 blood analyzer may fail quality checks more frequently during startup, causing the cartridge to be ejected. This can delay test results and may require multiple cartridge replacements. The GEM Premier 5000's built-in quality monitoring system (iQM2) will catch and reject any cartridges that do not pass validation, so cartridges that complete the validation process remain safe to use.
- Monitor GEM Premier 5000 startup for repeated cartridge ejection errors
- If you experience consecutive ejection errors, have replacement cartridges ready to minimize delays
- Ensure your iQM2 quality control program is active and functioning
- Contact Instrumentation Laboratory if you experience unusual error patterns
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-1531-2026More 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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