Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's 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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GEM Premier 5000 is a blood testing analyzer that uses GEM PAK cartridges for testing. The iQM2 program monitors the testing process, and AutoPAK Validation may allow a cartridge to remain in use after warm-up if validation completes.
A PCSND error during warm-up can cause consecutive ejections of GEM PAK cartridges, delaying test results and potentially impacting patient management.
This recall is not described as part of a broader industry pattern in the provided data.
The issue can disrupt lab turnaround times and patient management decisions, creating operational challenges for healthcare facilities.
Cartridge packaging and device software/logs typically display the part number, UDI, and lot codes.
Recall processing and replacements may take several weeks; facilities should plan accordingly (typical 4-8 weeks).
Keep records of all affected lot numbers, correspondence with the manufacturer, and any test result delays or patient management changes.
Model numbers and lot information are provided in the recall. Distribution is worldwide, including the US and numerous countries.
Confirmed customer complaints indicate PCSND errors during warm-up with consecutive GEM PAK ejections. No injuries or deaths are specified in the recall notice.
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