Instrumentation Laboratory recalled 1,629 GEM Premier 5000 cartridges worldwide on Jan. 20, 2026 after customers reported increased PCSND errors during warm-up. Consecutive ejections may prolong turnaround times and delay results. Stop using affected GEM PAKs and follow recall instructions from the manufacturer.
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 that uses GEM PAK cartridges to run patient samples in hospital or reference labs.
During warm-up, PCSND errors can trigger GEM PAK ejections and require insertion of a new PAK, potentially delaying results.
This recall is not described as part of a broader industry pattern.
Delays in test turnaround can affect patient management and decision-making in clinical settings.
Recall details are available on the FDA enforcement page linked in the notice and the manufacturer recall notification.
Remedy timelines vary; replacements or service are typically processed within weeks once the recall is executed.
Document cartridge lot numbers, UDI, purchase records, and all recall communications; retain imaging of the device label and cartridge packaging.
Model numbers: 00055415010 (Part No.) UDI: 08426950807698 Lots: 251114J, 251114K, 251114L, 251117AA, 251117F, 251117I, 251117L, 251117T, 251118A, 251118B, 251118C, 251119A, 251119B, 251124K, 251126D, 251126M, 251126N, 251126U Sold at: Worldwide distribution including US nationwide and many countries listed in recall notice Price: Unknown Status: Active recall Recall date: 2026-01-20 Distributor: Instrumentation Laboratory Product: GEM Premier 5000 chemistry analyzer cartridges
No injuries or incidents have been reported.
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