Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for detection errors
Check GEM Premier 5000 PAK cartridge 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 and need replacement. This can delay test results. The issue affects 51 cartridges from specific lot numbers distributed worldwide.
- Check if your GEM Premier 5000 uses PAK cartridges from lot numbers 251113U, 251201AI, 251202Q, 251223E, 251223P, or 251229X (Part No. 00055360004)
- If you have affected cartridges, monitor for repeated ejection errors during warm-up
- Have backup cartridges on hand to minimize testing delays
- Contact Instrumentation Laboratory if you experience consecutive cartridge ejections
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-1524-2026More Instrumentation Laboratory recalls
- 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
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for increased error rate
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