Recall Z-1977-2014 ยท OYE Flow Cytometric Reagents And Accessories.
BD Biosciences, Systems & Reagents
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
| Date | Jul 2, 2014 (initiated Jun 6, 2014) |
| Status | Terminated |
| Reason | Laser cooling fans and internal fan of the associated fluidics cart are not operational. |
| Root cause | Nonconforming Material/Component |
| Action | BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions. |
| Quantity | 35 installed devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.