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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC 600/800 with

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  Class 2 Device Recall UniCel DxC 600/800 with see related information
Date Initiated by Firm September 03, 2012
Date Posted October 24, 2012
Recall Status1 Terminated 3 on February 14, 2014
Recall Number Z-0123-2013
Recall Event ID 63143
510(K)Number K042291  K060256  K103842  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product UniCel¿ DxC 600/800 with
Software v5.0.11, Part Number B12218.

The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled 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).
Code Information Part Number B12218. Serial numbers 2329, 5477, 5479.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar
FDA Determined
Cause 2		 Software change control
Action Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call 714-993-5321.
Quantity in Commerce 7 units total (both US and International)
Distribution Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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