PlainRecalls
FDA Devices Low Class III Terminated

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 corre

Reported: August 8, 2018 Initiated: May 16, 2018 #Z-2598-2018

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.

Reason for Recall

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

Details

Units Affected
8 devices
Distribution
US Distribution was made to FL, KS, KY, MA, NJ, and SD.
Location
San Jose, CA

Frequently Asked Questions

What product 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.. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 8 devices.
Why was this product recalled? ▼
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Low. Recall number: Z-2598-2018.

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