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.

Z-2598-2018

May 16, 2018

Class III

Product summary

Firm: Becton, Dickinson and Company, BD Biosciences
Event: Event 80388
Status: Terminated
Classification: Class III
Quantity: 8 devices
Official record key: device-enforcement:Z-2598-2018

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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