Instrumentation Laboratory issued a high-severity recall for 1,126 GEM PAK cartridges used with the GEM Premier 5000. The recall cites increased PCSND errors during warm-up that can cause consecutive GEM PAK ejections. The issue may delay patient results. Hospitals should halt use and follow manufacturer instructions immediately.
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 coagulation and chemistry analyzer used in hospital labs to run patient samples. GEM PAK cartridges are consumables used with the analyzer.
PCSND errors during warm-up can cause cartridges to eject, potentially delaying test results and impacting patient care.
This recall is not described as part of a broader pattern in the provided data.
Delays in test results and potential reassessment of patient management during the recall period.
UDI on cartridge label; Lot numbers on packaging; recall notice via FDA enforcement site.
No specific refund timeline provided. Expect replacement or instructions per manufacturer communications.
Keep recall notices, order records, replacement receipts, and correspondence with the manufacturer.
Part No. 00055407510. Global distribution. Recall date 2026-01-20. Report date 2026-03-18. Price not disclosed.
1,126 units recalled. No injuries or deaths reported in the provided data.
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