BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

FDA device recall Z-1977-2014 · posted 2014-07-02 · Terminated

Recall details

Recalling firm

BD Biosciences, Systems & Reagents

Reason for recall

Laser cooling fans and internal fan of the associated fluidics cart are not operational.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OYE

Quantity affected

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.

Date initiated

2014-06-06

Date posted

2014-07-02

Date terminated

2015-01-27

Location

San Jose, CA