Instrumentation Laboratory is recalling 30 GEM Premier 5000 PAK cartridges distributed worldwide, including the United States. The affected cartridges may experience PCSND errors during warm-up, causing GEM PAKs to eject. Stop using the product and follow recall instructions from the manufacturer for refunds or replacements.
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 benchtop blood gas analyzer used for rapid metabolic and electrolyte testing. GEM PAK cartridges are consumables used within the system to perform the tests.
A PCSND error during warm-up can cause a GEM PAK to eject. If an AutoPAK Validation occurs after warm-up, the cartridge may continue to be used, delaying results and potentially affecting patient management.
This recall is not part of a broader industry pattern.
The recall could cause testing delays in clinical settings and require procedural adjustments to ensure timely patient care.
FDA recall enforcement page and the manufacturer recall notice; packaging and device labeling
Typically 4-6 weeks for refunds or replacements after dealer/manufacturer coordination
Preserve recall notices, take photos of cartridge labels and packaging, record serials and lot numbers, save all correspondence
Model numbers/part numbers: 00055360008 (Part No. 00055360008); UDI: 08426950807575; Lot Nos: 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X. Where sold: Worldwide distribution; US nationwide; countries include Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan,
Confirmed customer complaints indicate PCSND errors during warm-up with GEM PAK ejection. No specific injuries or fatalities are documented in the recall notice.
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