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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