GEM Premier 5000 PAK
Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to potential errors that may delay patient results.
If a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Contact your local Instrumentation Laboratory representative for further guidance or if you experience consecutive cartridge ejections.
Why it was recalled
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.
How to identify it
UPC 00055360004 08426950899662
GEM Premier 5000 PAK, Part No. 00055360004.
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification