Instrumentation Laboratory is recalling 25 GEM PAK cartridges for the GEM Premier 5000 after complaints of PCSND errors during warm-up. The issues can cause consecutive GEM PAK ejections. The recall affects units distributed worldwide to healthcare facilities. Stop using the affected cartridges and follow manufacturer 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 hospital blood gas analyzer that uses GEM PAK cartridges to measure critical blood gas and chemistry parameters.
A warm-up defect can cause PCSND errors and consecutive cartridge ejections. If AutoPAK Validation completes, the cartridge may continue to be used, prolonging disruption in testing.
This recall is not described as part of a broader industry pattern.
Hospitals may experience longer turnaround times for blood gas results and may need to reassess patient management while the issue is unresolved.
Cartridge labels and packaging include Part No., UDI, and lot numbers. Recall notices provide details.
Replacement or remediation timelines will be provided by the manufacturer; expect weeks to a couple of months in typical recalls.
Keep a log of cartridge lot numbers, dates of use, and any PCSND events. Save recall notices and manufacturer correspondence.
Part No. 00055430011. UDI: 08426950807766. Lots: 251114K, 251205K, 251215D. Distribution: Worldwide to healthcare facilities. Sold since unknown date. Price: Unknown.
Confirmed customer complaints describe increased PCSND errors during warm-up with consecutive ejections. No injury counts are provided in the recall notice.
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