Instrumentation Laboratory’s GEM Premier 5000 was recalled for 195 units distributed worldwide to hospitals and clinical labs. The recall follows complaints of increased Process Control Solution Not Detected errors during warm-up, which can eject GEM PAK cartridges. Hospitals should stop using the device immediately and contact IL for 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 laboratory analyzer used in clinical settings to measure blood parameters. It uses GEM PAK cartridges and is monitored by the iQM2 quality control program.
During warm-up, GEM PAKs may generate PCSND errors, causing cartridge ejections. This can disrupt testing and delay results.
This recall is not stated as part of a broader industry pattern.
Labs may experience onboarding delays and test turnaround time increases. Patient management decisions may be affected if results are delayed.
Serial numbers, date codes, and lot numbers typically appear on the device label and the GEM PAK cartridges.
No timeline is provided for refunds or service in the notice. IL will issue further guidance.
Keep recall notices, serial numbers, lot numbers, and all correspondence with IL and regulators.
Model numbers: Part No. 00055415008. Distribution: Worldwide to healthcare providers. Sold From: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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