GEM Premier 5000 recall announced for 1,989 units distributed worldwide, including the US and numerous other countries. The issue involves GEM PAK cartridges experiencing Process Control Solution Not Detected errors during warm-up, causing ejections and potential delays in patient results. Stop using the device and follow manufacturer 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 clinical chemistry analyzer platform used in laboratories to measure patient samples. It uses GEM PAK cartridges for testing and relies on iQM2 quality control. Typical use includes rapid, automated testing in hospital or reference labs.
PCSND errors during warm-up can eject GEM PAK cartridges, delaying test results and potentially impacting patient management.
This recall is part of a broader pattern of QC cartridge reliability issues in clinical analyzers.
Delays in results, potential reassessment of patient management, operational disruption for labs.
Recall notice on FDA enforcement page and Instrumentation Laboratory communications.
Expect recall resolution and replacements within 4-8 weeks, subject to stock and processing.
Preserve lot codes, part numbers, communications, replacement receipts, and test results impacted by delay.
Model numbers: Part No. 00055445010 and 00055445011. Distribution: Worldwide, including US nationwide and many countries listed. Recall date: 2026-01-20. Status: ACTIVE. Quantity: 1,989 units.
No specific injury counts provided in the data. The recall note references multiple customer complaints and operational disruption but does not report injuries.
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