Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #142 V2, V12 Mixer/Wash del

FDA device recall Z-2633-2011 · posted 2011-06-23 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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

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.

Root cause

Pending

Status

Terminated

Product code

JJE

Quantity affected

2392 units

Distribution

Worldwide Distribution - USA (Nationwide) and Canada

Date initiated

2009-07-23

Date posted

2011-06-23

Date terminated

2012-07-02

Location

Brea, CA

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