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FDA (Device enforcement)Recalled 2019-07-17closedclass ii

Becton Dickinson & Co.: Kit BD Max ExK DNA 2 USA; Catalog # 442819

Is my product affected?

Kit BD Max ExK DNA 2 USA; Catalog # 442819

  • UPC 00382904428198

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

What happened

Becton Dickinson & Co. is recalling the BD MAX ExK DNA 2 USA kit (Catalog # 442819) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected product is Lot #9114654 with an expiration date of November 7, 2020, and was distributed across numerous states including Alabama, Arizona, California, Florida, New York, and Texas, as well as internationally to countries including Australia, Canada, Japan, Mexico, and Singapore.

The recall notice does not specify a remedy or recommended course of action for affected consumers.

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

Hazard

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Details from the source

Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan Quantity: 0 Lot/code info: Lot #9114654; UDI (GTIN, DI+PI):(01)00382904428198 (17)201107(10)9114654(30)1; Exp: 11/7/2020

Source

Official record: FDA (Device enforcement) ↗

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

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