Recall Z-2247-2016 ยท LDT
Beckman Coulter Inc.
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.
| Date | Jul 20, 2016 (initiated Jun 27, 2016) |
| Status | Terminated |
| Reason | Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. |
| Root cause | 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 imp |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.