Company:Beckman Coulter Inc.
Date of Enforcement Report 3/13/2013
Class ll:
PRODUCT
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Recall Number Z-0913-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc.., Brea, CA on 11/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
28 in U.S.; 4 Canada; 318 to other foreign countries.
DISTRIBUTION
Nationwide and Internationally
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