FDA recall Z-2598-2018

Becton, Dickinson and Company, BD Biosciences · Class III · device

Product

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

Reason for recall

The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

Distribution

US Distribution was made to FL, KS, KY, MA, NJ, and SD.

Key facts

Status
Terminated
Initiation date
2018-05-16
Report date
2018-08-08
Termination date
2018-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2598-2018