Recall Z-2598-2018— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-2598-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-16

Class III · Terminated

Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2018-05-16, terminated 2018-08-13. It names one FDA 510(k) clearance: K170974. 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..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class III
Status: Terminated
Initiated: 2018-05-16
Terminated: 2018-08-13
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company·cleared 2017-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.