Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.
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 analyzer that uses GEM PAK cartridges to run tests. It is used in hospital laboratories to generate diagnostic results.
PCSND errors during warm-up may lead to GEM PAK cartridge ejection, potentially delaying test results and affecting patient management decisions.
This recall highlights potential operational disruptions in automated QC processes for clinical analyzers.
Delays in test turnaround times may require reassessment of patient management and treatment decisions.
Look for Part No, UDI, and Lot numbers on the device label or accompanying documentation.
Recall timeline and remediation steps will be provided by IL; no specific timeframe is given here.
Preserve the recall notice, record serials, dates of purchase, and correspondence with IL. Document patient impact if any.
Model numbers: 00055415011 (Part No). UDI: 08426950807704. Lots No.: 251215D. Distribution: Worldwide distribution. Sold from unknown dates. Price: Unknown. Quantity: 7 units.
No injuries or incidents have been reported.
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