Instrumentation Laboratory recalled 27 GEM Premier 5000 PAK cartridges sold to healthcare facilities worldwide after reports of PCSND errors during warm-up. Consecutive ejections may delay test results. Clinicians should stop using the affected cartridges and await manufacturer 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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The GEM Premier 5000 is a clinically used analyzer that uses GEM PAK cartridges for quality control. Labs rely on AutoPAK Validation to validate performance.
PCSND errors during warm-up can trigger consecutive GEM PAK ejections, delaying results and potentially impacting patient management.
This recall is not a broader industry pattern.
Delays in test results and potential reassessment of patient management until results are available.
Recall notices from Instrumentation Laboratory and FDA enforcement page. Look for product labels showing the part number, UDI, or lot codes.
Replacement or remediation timeline is not specified in the notice.
Keep the recall notice, part number, UDI, and lot codes; log all communications with the manufacturer and clinical impact on patient management.
Part number: 00055407511. UDI: 08426950807643. Lots: 251114K, 251201X, 251215D. Distribution: Worldwide, including US and listed countries. Recall date: 2026-01-20. Status: ACTIVE.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Instrumentation Laboratory recalled 1,607 GEM Premier 5000 units worldwide after complaints of PCSND errors during warm-up that eject GEM PAK cartridges. iQM2 monitors the process and may allow continued use after AutoPAK Validation. Stop using the device and follow IL recall instructions.
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.
Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.
Instrumentation Laboratory recalls 8 GEM Premier 5000 cartridges worldwide after PCSND warm-up errors cause GEM PAK ejections. The defect may prolong turnaround times and delay results. Hospitals and clinics should stop using the device and contact the manufacturer for instructions.
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.
Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's recall instructions.
Instrumentation Laboratory recalled 70 GEM Premier 5000 GEM PAK cartridges worldwide on 2026-01-20 after confirmed PCSND errors during warm-up. Consecutive ejections may prolong turnaround times. Stop using the device and contact Instrumentation Laboratory for instructions.
A worldwide distribution recall covers 74 GEM PAK cartridges for the GEM Premier 5000. The issue involves PCSND errors during warm-up that can trigger ejection of GEM PAKs and may delay results. Institutions should follow recall instructions from Instrumentation Laboratory and notify healthcare teams immediately.