Instrumentation Laboratory recalled 70 GEM Premier 5000 GEM PAK cartridges worldwide on 2026-01-20 after confirmed PCSND errors during warm-up. Consecutive ejections may prolong turnaround times. Stop using the device and contact Instrumentation Laboratory for instructions.
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 laboratory testing system that uses GEM PAK cartridges to perform certain assays in healthcare settings. The device is used to support clinical decision making and patient management.
PCSND errors during warm-up can cause cartridge ejection. If AutoPAK Validation completes after warm-up, the GEM PAK may remain in use, potentially delaying test results and impacting patient management.
This recall is not described as part of a broader industry pattern.
Consecutive ejections may disrupt workflow and delay critical results in clinical settings. Hospitals and labs may need advance planning to minimize impact.
Recall details are available from Instrumentation Laboratory and the FDA enforcement page linked in the recall notice. Check packaging and labeling for part number and UDI.
No specific timeline for refunds or replacements is provided in the notice.
Keep copy of recall notice, packaging, lot numbers, and any correspondence with the manufacturer for records.
Part Number: 00055445008. UDI: 08426950807797. Lots: 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, 251215K. Quantity: 70 units. Sold worldwide, including US nationwide and listed countries. Model reference includes Part number and lot codes associated with GEM Premier 5000 GEM PAK cartridges.
The recall cites confirmed customer complaints of PCSND errors during warm-up and ensuing GEM PAK ejections. No specific injury data is provided in the notice.
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