Home / Recalls / Becton, Dickinson And Company, BD Biosciences / Z-2598-2018

Z-2598-2018 Class III Terminated

Recalled by Becton, Dickinson And Company, BD Biosciences — San Jose, CA

FDA device recall Z-2598-2018 was initiated by Becton, Dickinson And Company, BD Biosciences on May 16, 2018 and is designated Class III. Reason for recall: The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use. The recall status is terminated (terminated Aug 13, 2018). Affected quantity: 8 devices.

Recall Details

Product Type: Devices
Report Date: Aug 8, 2018
Initiation Date: May 16, 2018
Termination Date: Aug 13, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 devices

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.

Distribution Pattern

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

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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2598-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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