Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s recall 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 hospital/clinical laboratory analyzer that uses GEM PAK cartridges for testing.
During warm-up, PCSND errors can cause cartridge ejection and may delay results, impacting patient management.
This recall is not indicated as part of a broader industry pattern in the provided data.
Operational delays in test results and potential need for reassessment of patient management while awaiting results.
Refer to the FDA enforcement page and the manufacturer’s recall notices for identifiers and instructions
Remedy processing may take weeks; typical timeframe cited is 4-8 weeks for replacement or refunds where applicable
Keep recall notices, batch numbers, UDI, purchase records, and all correspondence with the manufacturer.
Part No.: 00055360010 UDI: 08426950807599 Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q Distribution: Worldwide (US nationwide and many countries listed) Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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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 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.
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.
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.