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Recall Observatory FDA recall evidence

Device 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.

Z-2247-2016

June 27, 2016

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 74559
Status
Terminated
Classification
Class II
Quantity
4,221 units total (2,033 units in US)
Official record key
device-enforcement:Z-2247-2016

Official wording

Reason: Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

Code information: All

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.