Instrumentation Laboratory GEM Premier 5000 cartridges recalled for increased detection errors
Check your GEM Premier 5000 cartridges
Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer are experiencing increased errors during startup that cause the cartridge to eject prematurely. This may require staff to insert a new cartridge and repeat the startup process, which can delay test results. The device's built-in quality monitoring system (iQM2) continues to verify results, so cartridges that pass validation can remain in use.
- If you operate a GEM Premier 5000, monitor for repeated cartridge ejections during warm-up on lots 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, or 251230P
- Plan ahead for potential delays if cartridge ejections occur; have extra cartridges and staff available
- Contact Instrumentation Laboratory customer support if you experience consecutive cartridge ejections
- Continue using cartridges that pass the AutoPAK validation step after warm-up—they have been verified as safe
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-1538-2026More 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 cartridge ejection errors
- FDA-Device2026-03-18Instrumentation Laboratory GEM Premier 5000 PAK cartridges recalled for increased error rate
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