Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s 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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The GEM Premier 5000 is a hospital/clinical laboratory analyzer that uses GEM PAK cartridges for testing.
During warm-up, PCSND errors can cause cartridge ejection and may delay results, impacting patient management.
This recall is not indicated as part of a broader industry pattern in the provided data.
Operational delays in test results and potential need for reassessment of patient management while awaiting results.
Refer to the FDA enforcement page and the manufacturer’s recall notices for identifiers and instructions
Remedy processing may take weeks; typical timeframe cited is 4-8 weeks for replacement or refunds where applicable
Keep recall notices, batch numbers, UDI, purchase records, and all correspondence with the manufacturer.
Part No.: 00055360010 UDI: 08426950807599 Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q Distribution: Worldwide (US nationwide and many countries listed) Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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