Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Recall Summary Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges (Part No. 00055407504) used for blood gas and pH testing because they may repeatedly fail with "Process Control Solution Not Detected" errors during warm-up, causing the cartridge to be ejected and requiring replacement. This malfunction can delay test results and patient care decisions. The cartridges are distributed worldwide, including throughout the United States.
- Recalling firm
- Instrumentation Laboratory
- Product
- GEM Premier 5000 PAK; Part No. 00055407504.
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f75120b9-18ed-4a99-a436-ab7d6fbee73d