Instrumentation Laboratory recalled 27 GEM Premier 5000 PAK cartridges sold to healthcare facilities worldwide after reports of PCSND errors during warm-up. Consecutive ejections may delay test results. Clinicians should stop using the affected cartridges and await 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 clinically used analyzer that uses GEM PAK cartridges for quality control. Labs rely on AutoPAK Validation to validate performance.
PCSND errors during warm-up can trigger consecutive GEM PAK ejections, delaying results and potentially impacting patient management.
This recall is not a broader industry pattern.
Delays in test results and potential reassessment of patient management until results are available.
Recall notices from Instrumentation Laboratory and FDA enforcement page. Look for product labels showing the part number, UDI, or lot codes.
Replacement or remediation timeline is not specified in the notice.
Keep the recall notice, part number, UDI, and lot codes; log all communications with the manufacturer and clinical impact on patient management.
Part number: 00055407511. UDI: 08426950807643. Lots: 251114K, 251201X, 251215D. Distribution: Worldwide, including US and listed countries. Recall date: 2026-01-20. Status: ACTIVE.
No injuries or incidents have been reported.
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