Instrumentation Laboratory recalled 51 GEM Premier 5000 PAK cartridges worldwide after complaints of PCSND errors during warm-up. These errors can cause GEM PAK cartridges to eject. The recall could delay results and affect patient management. Stop using the affected cartridges and follow recall instructions from Instrumentation Laboratory.
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 chemistry analyzer used for patient testing. GEM PAK cartridges are consumables that perform specific tests within the instrument.
PCSND errors during warm-up can cause GEM PAKs to eject. If AutoPAK Validation completes, the cartridge may remain in use, potentially delaying results and impacting patient management.
This recall is not identified as part of a broader industry pattern.
Affects labs and facilities using the GEM Premier 5000; delays in test results can affect timely patient care and decision-making.
Cartridge label and packaging for Part No. 00055360004
No specific remediation timeline provided; follow manufacturer instructions for replacement process
Keep records of all recall notifications, cartridge batch numbers, and communications with the manufacturer
Product: GEM Premier 5000 PAK cartridge Part No.: 00055360004 UDI: 08426950899662 Lot Nos.: 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X Sold worldwide, including US nationwide and numerous countries listed by the FDA recall Recall date: 2026-01-20 Status: ACTIVE Quantity recalled: 51 units Manufacturer: Instrumentation Laboratory Categories: Health & Personal Care, Medical Devices Model/Part family: GEM Premier 5000 PAK cartridge
No injuries or incidents have been reported.
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