Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC 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)
This recall has been terminated (originally issued June 23, 2011).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 23, 2009
- Posted
- June 23, 2011
- Terminated
- July 2, 2012
- Recall Number
- Z-2633-2011
- Quantity
- 2392 units
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. The impact of this issue would include: (1) Quality Control and patient results can potentially be affected. (2) If system has been calibrating properly and Quality Control is recovering within es
Distribution
Worldwide Distribution - USA (Nationwide) and Canada
Lot / Code Info
All serial numbers
Root Cause
Pending
Action Taken
Beckman Coulter sent out an "Urgent Product Corrective Action" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions: " If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada. " This issue will be corrected with an upcoming software version and tubing modification. " Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records. Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.