Instrumentation Laboratory recalled 1,607 GEM Premier 5000 units worldwide after complaints of PCSND errors during warm-up that eject GEM PAK cartridges. iQM2 monitors the process and may allow continued use after AutoPAK Validation. Stop using the device and follow IL recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Instrumentation Laboratory or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The GEM Premier 5000 is a clinical laboratory analyzer used in hospitals and labs to run quality control cartridges known as GEM PAKs.
During warm-up, PCSND errors may occur, causing GEM PAKs to eject. If an AutoPAK Validation completes, the cartridge may remain in use, potentially delaying results and affecting patient management.
This recall is not described as part of a broader industry pattern.
Labs may face turnaround delays and need to reassess patient management for affected runs until issues are resolved.
GEM PAK labels and device documentation display the lot numbers, UDI, and model numbers.
4-8 weeks for refund or replacement processing after notification, per typical recall timelines.
Document all communications with IL, notices received, unit serials, lot numbers, and affected results during the recall period
Model numbers: 00055430010. UDI: 08426950807759. Lots No.: 251021K, 251027AA, 251110AH, 251114K, 251114O, 251114P, 251114Y, 251117AA, 251117AC, 251117AG, 251117AM, 251117AN, 251117P, 251117T, 251117V, 251117Y, 251118A, 251118B. Distribution: Worldwide; US Nationwide and many countries listed. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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