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Terminated

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.

FDA Recall Z-2272-2016 · Posted 2016-07-22

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-04-22
Date Terminated2017-02-09
Product Quantity3,540 units total (1,067 units in US)

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103842UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0Beckman Coulter, Inc. · 2011-04-27K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBeckman Coulter, Inc. · 2006-02-27K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc. · 2004-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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