Becton, Dickinson and Company, BD Biosciences recalls BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The…

Recall date

May 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2598-2018

FDA classification

Class III

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.