253 GEM Premier 5000 cartridges are recalled worldwide. Instrumentation Laboratory identified PCSND errors during warm-up that eject GEM PAKs and may delay results. Stop using affected cartridges and follow IL guidance for remediation with healthcare providers.
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 testing device used in healthcare settings to run certain assays with GEM PAK cartridges. It relies on iQM2 for continuous monitoring during testing.
A warm-up PCSND error can eject GEM PAK cartridges, delaying results and potentially impacting patient management.
This recall is not described as part of a broader industry pattern.
Hospitals and labs may experience delays in test results. Backups and re-testing could affect patient flow and management decisions.
Cartridge packaging and labels include Part number, UDI, and lot numbers.
Replacement or remediation timelines vary; expect weeks for processing after confirmation.
Keep recall notices, inventory lists, and correspondence with IL; document testing delays and actions taken
Part number 00055430004; UDI 08426950807711. Lots affected include 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J. Worldwide distribution. No price information available.
No injuries or incidents have been reported.
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