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

Becton Dickinson & Co.: Kit BD Max Enteric Viral Panel EU Catalog # 443985

Is my product affected?

Kit BD Max Enteric Viral Panel EU Catalog # 443985

  • UPC 00382904439859

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

What happened

Becton Dickinson & Co. is recalling 469 units of the BD MAX Enteric Viral Panel EU (Catalog # 443985) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected units include two lots: Lot # 9085674 (expiration 11/1/2020) and Lot # 9107980 (expiration 11/7/2020). These products were distributed across multiple U.S. states and internationally to countries including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.

The recall source does not specify a remedy or instructions 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: 469 units Lot/code info: Lot # 9085674; UDI (GTIN, DI+PI): (01)00382904439859 (17)201101(10)9085674(30)1; Exp: 11/1/2020 Lot # 9107980; UDI (GTIN, DI+PI): (01)00382904439859 (17)201107(10)9107980(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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