Instrumentation Laboratory recalls 8 GEM Premier 5000 cartridges worldwide after PCSND warm-up errors cause GEM PAK ejections. The defect may prolong turnaround times and delay results. Hospitals and clinics should stop using the device and contact the manufacturer 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 point-of-care blood gas and chemistry analyzer used by healthcare facilities. It relies on GEM PAK cartridges for measurements.
During warm-up, GEM PAK cartridges may produce PCSND errors leading to cartridge ejection. AutoPAK Validation may allow continued use, potentially delaying results and impacting patient management.
This recall is not described as part of a broader industry pattern.
Delays in test results can affect patient care decisions and require reassessment of patient management while awaiting accurate readings.
On the cartridge label and packaging. Manufacturer recall notices provide identification details.
No timeline for remedy provided in the release. Recall status is ACTIVE as of 2026-03-18.
Keep copies of all recall communications, log PCSND incidents, and document corrective actions taken.
Model numbers: Part number 00055415005; UDI 08426950807667; Lots Nos. 251125S, 251201AJ, 251212O, 251218V, 251229X. Sold worldwide to healthcare facilities. Price and sold date not disclosed.
No injuries or incidents have been reported.
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