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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