Becton, Dickinson and Company, BD Biosciences: 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,

Is my product affected?

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 t

• UPC 2662879000001
• UPC 00382906628794
• UPC 2662879000002
• UPC 2662879000003
• UPC 2662879000004
• UPC 2662879000009
• UPC 2662879000010
• UPC 2662879000011
• UPC 2662879000012

Check against the official notice below — it lists the full affected range.

What happened

Becton, Dickinson and Company is recalling the BD FACS Universal Loader (Model 662879), an optional component for the BD FACSLyric Clinical System. The solenoid plunger tip on the affected units is too short, which prevents proper locking engagement with the Universal Loader enclosure during use. Eight devices were distributed to facilities in Florida, Kansas, Kentucky, Massachusetts, New Jersey, and South Dakota.

The affected units have serial numbers 2662879000001 through 2662879000004, 2662879000009 through 2662879000012. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: US Distribution was made to FL, KS, KY, MA, NJ, and SD. Quantity: 8 devices Lot/code info: 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

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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