Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for detection errors
Check your GEM Premier 5000 PAK lot number
Instrumentation Laboratory GEM Premier 5000 PAK cartridges (part number 00055360008) in certain lots 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. The quality control system will catch cartridges that fail validation, and affected cartridges can still be used if they pass validation.
- Check if your GEM PAK lot number matches: 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, or 251229X
- If you have an affected lot, monitor for repeated cartridge ejections during warm-up
- Contact Instrumentation Laboratory if you experience consecutive cartridge ejections
- Plan ahead for possible operational delays during testing
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-1525-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief