BD FACS Universal Loader Recalled for Insufficient Locking Mechanism

Plain-English summary

Becton, Dickinson and Company, BD Biosciences is recalling 8 units of the BD FACS Universal Loader (Model 662879) for the BD FACSLyric Clinical System. The recall is due to a defect where the solenoid plunger tip length is too short, resulting in insufficient engagement with the Universal Loader enclosure to lock during use.

The affected devices were distributed in the United States to facilities in Florida, Kansas, Kentucky, Massachusetts, New Jersey, and South Dakota. The specific serial numbers for the recalled units are 2662879000001, 2662879000002, 2662879000003, 2662879000004, 2662879000009, 2662879000010, 2662879000011, and 2662879000012.

This recall is classified as Class III by the FDA, indicating that the defect is not likely to cause adverse health consequences. Users should check their device serial numbers against the list provided and contact the manufacturer for instructions on replacement or repair.

The recalled product

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 c

Manufacturer

Becton, Dickinson and Company, BD Biosciences

Category

Medical Device — Laboratory Equipment

Hazard

• mechanical-defect

Affected units

8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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