GEM PAKs for GEM Premier 5000 Recalled Due to Potential Operational Delays
Instrumentation Laboratory Co. has issued a recall for specific GEM PAK cartridges used with the GEM Premier 5000 system due to errors that may cause premature ejection and delay patient testing.
What Happened
Instrumentation Laboratory Co. has confirmed customer complaints regarding specific GEM PAK cartridges used with the GEM Premier 5000 system. The affected units may experience an increased incidence of “Process Control Solution Not Detected” (PCSND) errors during the warm-up phase. These errors result in the automatic ejection of the GEM PAK, requiring the user to insert a new cartridge. While the iQM2 quality process control program ensures that any cartridge completing validation is safe for use, consecutive ejections can lead to operational disruptions.
Which Products Are Affected
The recall involves several models of the GEM PAK for the GEM Premier 5000 with iQM2. Affected model or catalogue numbers include:
- 00055415004, 00055430004, 00055445004: Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
- 00055430011, 00055415011: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2
- 00055360008, 00055407508: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
There are more than 10 affected lot numbers. Consumers are advised to contact the manufacturer for a full list of specific serial and lot numbers.
What You Should Do
Health Canada notes that if a GEM PAK successfully completes the AutoPAK validation following its warm-up, it may remain in use. However, because consecutive ejections can occur, healthcare facilities should implement advance planning to minimize the impact of potential testing delays. For further information or to verify specific lot numbers, contact Instrumentation Laboratory Co. at 180 Hartwell Road, Bedford, Massachusetts, 01730-2443.
Why This Matters
Consecutive GEM PAK ejections during the warm-up phase can prolong turnaround times for critical diagnostic results. These delays may potentially postpone appropriate patient management and require clinical reassessment once results finally become available.
Source
Source: Health Canada Official Notice