12
Nov
2010

860i & 600i Systems; SofwareCl ll UniCel DxC 880i

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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