FDA Device recall Z-2598-2018

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only

• FDA Device
• Class III
• terminated
• Published 2018-08-08

On 2018-08-08 the FDA classified a Class III recall of BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only by Becton Dickinson And Bd Biosciences, citing the solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

Read the official FDA Device notice

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

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2598-2018%22

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