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Gem paks for the gem premier 5000 with iqm2
Official notice
17 Mar 2026
Last checked
17 Mar 2026
An official Health Canada notice concerns Gem paks for the gem premier 5000 with iqm2. 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. Published 2026-03-17.
What to do now
Contact the manufacturer if you require additional information. CONTACT WERFEN TECHNICAL SUPPORT AT 1-800-678-0710
Recall number
81732
Official notice
2026-03-17
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
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Brand: Instrumentation Laboratory.
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