Instrumentation Laboratory recalls 489 GEM Premier 5000 PAK cartridges worldwide after reports of Process Control Solution Not Detected errors during warm-up. iQM2 monitors the testing process and may allow continued use after AutoPAK Validation. The recall highlights potential operational disruptions in patient management.
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 clinical chemistry analyzer used in laboratories to run blood gas and chemistry tests.
PCSND errors during warm-up can eject a GEM PAK, delaying results and potentially affecting patient management.
This recall is not part of a broader industry pattern.
Delays in diagnostic results may affect patient management timelines and scheduling.
Review device labels, packaging, or supplier communications for lot numbers and UDI.
Timeline varies; expect recall communications from IL for refunds/replacements.
Document all communications with IL and clinical impact notes for patients.
Model numbers and lot codes: Part No. 00055407504. Quantity: 489 units. Distribution: Worldwide, including US and listed countries.
High hazard level based on 489 units recalled and multiple complaints of PCSND errors during warm-up. No specific injury reports are provided in the summary.
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