Instrumentation Laboratory recalled 10 GEM Premier 5000 PAK cartridges sold worldwide after reports of increased PCSND errors during warm‑up. The issue can cause GEM PAK ejections and delays in results. Clinicians and labs should follow the manufacturer’s recall instructions and seek guidance from their healthcare provider.
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 medical device used for critical diagnostic testing in healthcare settings. Cartridges called GEM PAKs are consumables used within the system.
PCSND errors during warm-up can lead to PAK ejection and testing delays. iQM2 continues monitoring, but repeated ejections may disrupt workflows.
This recall is not part of a broader pattern described in the notice.
Delays in test results, potential reassessment of patient management, operational disruption.
Manufacturer’s recall notice or FDA enforcement page; contact Instrumentation Laboratory for instructions
Refunds or replacements will follow manufacturer guidance, typically within weeks
Keep purchase receipts, packaging, recall notices, and correspondence with the manufacturer
Product: GEM Premier 5000 PAK; Part No. 00055360011. Quantity: 10 units. Distribution: Worldwide. Recall date: 2026-01-20. Manufacturer: Instrumentation Laboratory. Model/UDI: Part number 00055360011; UDI 08426950807605; Lot No. 251119A.
No injury or death data supplied in the available recall notice. The notice cites several customer complaints of PCSND errors and subsequent ejections during warm-up.
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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.
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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.