Instrumentation Laboratory recalled 130 GEM PAK cartridges for the GEM Premier 5000 after confirmed complaints of Process Control Solution Not Detected errors during warm-up. The issue can cause GEM PAKs to eject and delay test turnaround. Healthcare facilities should stop using the affected cartridges and follow manufacturer instructions for recall guidance.
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 laboratory analyzer used for clinical testing. It utilizes GEM PAK cartridges and AutoPAK Validation to monitor testing processes.
PCSND errors during warm-up may cause GEM PAKs to eject. Subsequent use of a cartridge after an ejection can delay test results and affect patient management.
This recall is not described as part of a broader industry pattern.
Laboratories may experience slower turnaround times and need to reassess patient management while awaiting results.
Recall notices and lot-specific instructions are available through the FDA enforcement page and issuer communications from Instrumentation Laboratory.
Typical recall remedy processing may take several weeks (the standard window is 4-8 weeks for refunds or replacements).
Retain copies of recall notices, lot numbers, replacement receipts, and communications with the manufacturer.
Model numbers: Part number 00055445004. UDI: 08426950807773. Lots: 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 251229AG, 251229X, 251230P. Distribution: Worldwide (US nationwide and numerous countries). Sold since unknown. Price: Unknown.
Confirmed customer complaints describe PCSND errors and GEM PAK ejections during warm-up. No injuries or incidents are detailed in the recall summary.
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