Official recall record

GEM PAKs for the GEM Premier 5000 with iQM2

What the authority reported

The company confirmed customer complaints indicating that specific 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 appropriate patient management. In such cases, patient management may require reassessment once results are available. While many GEM PAK s 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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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