Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
- Recalling firm
- Instrumentation Laboratory
- Product
- GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
- Reason
- The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5b40a5af-c187-4ef7-86b4-444918dafc4f