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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Systems No Foam DxC, Reference No. B64130

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  Class 2 Device Recall Synchron Systems No Foam DxC, Reference No. B64130 see related information
Date Initiated by Firm June 27, 2016
Date Posted July 20, 2016
Recall Status1 Terminated 3 on August 25, 2017
Recall Number Z-2247-2016
Recall Event ID 74559
Product Classification Reagent, general purpose - Product Code LDT
Product The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
Code Information All
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Mark Price
714-9935321
Manufacturer Reason
for Recall
Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.
FDA Determined
Cause 2
Under Investigation by firm
Action A Customer notification letter dated 6/27/16 informs their customers that Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. The letter informs their customers that the DxC No Foam reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the hydropneumatic subsystems. Over time, this incompatibility may lead to: Breaks in No Foam Cap Assembly (PN A84827) and Cracks in No Foam Waste Collector (PN A60007/A64665). The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the recall notice are instructed to contact our Customer Support Center Via http://www.beckmancoulter.com/customersupport/support ¿ Via phone, call 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada, are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 4,221 units total (2,033 units in US)
Distribution Affected geographies: United Arab Emirates, Curacao, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brunei, Canada, Switzerland, Colombia, Costa Rica, Czech Republic, Germany, Ecuador, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Ireland, India, Iraq, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Macao, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, China, United States of America (including Puerto Rico), Viet Nam, Mayotte, South Africa.

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.
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