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

Becton Dickinson & Co.: Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

Is my product affected?

Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

  • UPC 00382904428181

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

What happened

Becton Dickinson & Co. is recalling 447 units of the BD MAX ExK DNA 1 EU LUO kit (Catalog # 442818) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected units include Lot# 9085668 (expiration 10/24/2020) and Lot# 9106887 (expiration 11/7/2020), and were distributed across multiple U.S. states, Puerto Rico, and numerous countries including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.

The recall record 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 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: 447 units Lot/code info: Lot# 9085668; UDI (GTIN, DI+PI):(01)00382904428181 (17)201024(10)9085668(30)1; Exp:10/24/2020 Lot # 9106887; UDI (GTIN, DI+PI):(01)00382904428181 (17)201107(10)9106887(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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