Company: Beckman Coulter, Inc.
Date of Enforcement Report 11/10/2010
Class ll:
PRODUCT
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Recall # Z-2590-2010
REASON
Product may exhibit issues with stat sample rack loading, causing a possible delay in results.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter, dated March 25, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 unit
DISTRIBUTION
CA, IN, GA, NC, OH, SC, and WI
