Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for detection errors
Check GEM Premier 5000 PAK lot numbers
Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. Most cartridges continue to work normally, but consecutive failures may disrupt lab operations.
- Check if your GEM PAK cartridges match one of the affected lot numbers (251111O through 260102F, Part No. 00055415004)
- If affected, monitor for repeated cartridge ejections during warm-up
- Contact Instrumentation Laboratory for guidance on replacement or corrective action
- Plan for potential delays in test turnaround time during the transition
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-1532-2026More 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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