Instrumentation Laboratory recalls 352 GEM PAK cartridges for the GEM Premier 5000 worldwide due to increased PCSND errors during warm-up, risking delayed results. Medical facilities should stop using affected GEM PAKs and follow recall instructions. Manufacturers will provide further guidance to healthcare providers and patients.
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 lab analyzer cartridge system used in clinical chemistry to process tests with PAK cartridges. Clinicians rely on rapid results for patient management.
PCSND errors during warm-up may cause cartridge ejections, delaying results and potentially impacting patient treatment decisions.
This recall is not part of a broader industry pattern; it highlights quality control challenges within cartridge-based analyzers.
Hospitals may experience workflow delays due to repeated PAK ejections, requiring advance planning and potential resampling.
UDI on cartridge packaging and the lot number on the label
Replacement or refund timelines will be provided by Instrumentation Laboratory per recall notification
Keep packaging, batch numbers, correspondence, and any affected PAKs as evidence.
Product: GEM Premier 5000 PAK cartridges, Part No. 00055415004. Quantity: 352 units. Distribution: Worldwide, including US nationwide and listed countries. Lots/UDI: UDI 08426950807650; Lots Nos. 251111O, 251112P, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251202Q, 251203Q, 251208AA, 251209T, 251212O, 251216K, 251217I, 251217J. Recall date: 2026-01-20. Status: Active. Hazard level: High.
No specific incident counts beyond the reported PCSND errors and ejections. The recall cites patient management may require reassessment due to potential delays.
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