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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Instrumentation Laboratory recalled 1,607 GEM Premier 5000 units worldwide after complaints of PCSND errors during warm-up that eject GEM PAK cartridges. iQM2 monitors the process and may allow continued use after AutoPAK Validation. Stop using the device and follow IL recall instructions.
253 GEM Premier 5000 cartridges are recalled worldwide. Instrumentation Laboratory identified PCSND errors during warm-up that eject GEM PAKs and may delay results. Stop using affected cartridges and follow IL guidance for remediation with healthcare providers.
Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.
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.
Instrumentation Laboratory’s GEM Premier 5000 was recalled for 195 units distributed worldwide to hospitals and clinical labs. The recall follows complaints of increased Process Control Solution Not Detected errors during warm-up, which can eject GEM PAK cartridges. Hospitals should stop using the device immediately and contact IL for instructions.
Instrumentation Laboratory recalled 27 GEM Premier 5000 PAK cartridges sold to healthcare facilities worldwide after reports of PCSND errors during warm-up. Consecutive ejections may delay test results. Clinicians should stop using the affected cartridges and await manufacturer instructions.
Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's recall instructions.
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.