The Synchron Systems No Foam DxC recall
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are…
Why was The Synchron Systems No Foam DxC recalled?
Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All
- 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…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 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.
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)