Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Recall Summary Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges (Part No. 00055360004) used for blood gas and pH testing because they may experience repeated error messages during startup that cause the cartridge to be ejected, requiring replacement with a new one. This issue has been confirmed through customer complaints and may slow down test results. The product has been distributed worldwide, including across all U.S. states and territories.

Recalling firm: Instrumentation Laboratory
Product: GEM Premier 5000 PAK, Part No. 00055360004.
Reason: 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,...
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-01-20
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia,...

Recall details on Nibble Recalls: https://trynibble.app/recalls/3399b0ec-10c1-4bc0-8274-7ca02610a232