GEM Premier 5000; Part No. 00055430011.

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.

An URGENT MEDICAL DEVICE CORRECTION notice was sent to consignees on 1/20/26 was sent to consignees. The notice instructs consignees to continue to use affected devices with the provided warmup instructions. Consignees are to inform all laboratory staff of this notification and forward the notification if product was further distributed. A copy of the notification is to be maintained in consignee records. Consignees may contact Werfen Technical Support at 1-800-678-0710 for a replacement if a GEM PAK experiences a Process Control Solution Not Detected error.