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

Becton Dickinson & Co.: Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

Is my product affected?

Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

  • UPC 00382904428204

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 EU LUO kit (Catalog # 442820) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected product is Lot # 9114655 with an expiration date of November 7, 2020, and only 10 units were involved in this recall. The product was distributed across numerous U.S. states and territories, as well as internationally to countries including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.

The recall record does not specify a remedy or recommended 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: 10 units Lot/code info: Lot # 9114655; UDI (GTIN, DI+PI): (01)00382904428204 (17)201107(10)9114655(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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