Beckman Coulter Inc, Brea, Calif, continues its Class II Recall of the Beckman Coulter AU5800 clinical chemistry analyzer.
It recalled the device—an automated chemistry analyzer that measures analytes such as glucose, magnesium, and potassium—on November 28, 2012. Due to a software data storage limitation, which only occurs under certain conditions, measurements of the reagent blank (RB) or calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
The voluntary recall affects 28 analyzers in the US, four in Canada, and 318 distributed to foreign countries, including Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, the United Kingdom, and Viet Nam.
Click here to read more in the FDA Enforcement Report for the week of March 13, 2013.