Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2018 - (Recall #: Z-2598-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: May 16, 2018

Date Posted: August 8, 2018

Recall Number: Z-2598-2018

Event ID: 80388

Reason for Recall:

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

Status: Terminated

Product Quantity: 8 devices

Code Information:

Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001; Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002; Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003; Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004; Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009; Serial #2662879000010; UDI (01)00382906628794(11 )170915(21)Z662879000010; Serial #2662879000011; UDI (01)00382906628794(11)170915(21)Z662879000011; and Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated