UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Par

FDA device recall Z-2272-2016 · posted 2016-07-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.

Action taken

An Important Product Notice dated 4/22/14 was sent to all their customers to inform them that Beckman Coulter has identified a manufacturing issue with a plastic fitting on the No Foam Bottle Assembly which may crack and cause No Foam solution to leak. The letter informs the customers of the impact, action to be taken, and resolution. Customers are asked to inspect the No Foam Bottle Assembly for leaks prior to refilling the bottle. If leaks occur, customers should contact Customer Support Center following the instructions provided. Customers are instructed to complete the enclosed response form within 10 days. Customers with questions are instructed to contact the firm's Customer Support Center - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada, contact your local Beckman Coulter Representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJE

Quantity affected

3,540 units total (1,067 units in US)

Distribution

Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finlan

Date initiated

2014-04-22

Date posted

2016-07-22

Date terminated

2017-02-09

Location

Brea, CA

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