Recall Z-1977-2014
BD Biosciences, Systems & Reagents · initiated June 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Codes / lots: FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.
Reason for recall
Laser cooling fans and internal fan of the associated fluidics cart are not operational.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1977-2014
- Initiated
- June 6, 2014
- Posted by FDA
- July 2, 2014
- Terminated
- January 27, 2015
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- 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.
- Recalling firm
- BD Biosciences, Systems & Reagents, San Jose, CA