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.
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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GEM Premier 5000 is a clinical chemistry analyzer that uses GEM PAK cartridges to perform assays in medical settings.
PCSND errors during warm-up can cause GEM PAK ejections, delaying test results and affecting patient management.
This recall is not described as part of a broader industry pattern.
Delays in results and potential need for reassessment of patient management during outages.
FDA recall page and Instrumentation Laboratory recall communications
Manufacturer advises stopping use now; replacement or refund timelines to be provided by Instrumentation Laboratory
Keep copy of recall notice, lot numbers, procurement records, and communications with the manufacturer
Model/Part No.: GEM Premier 5000, Part No. 00055430008. Lots No.: 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, 251230P. UDI: 08426950807735. Quantity: 74 units. Distribution: Worldwide.
The recall cites confirmed customer complaints of PCSND errors during warm-up with consecutive ejections. No specific injuries or fatalities are described in the documentation.
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