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

Becton Dickinson & Co.: Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

Is my product affected?

Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

  • UPC 00382904429638

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

What happened

Becton Dickinson & Co. is recalling 994 units of the BD MAX Enteric Bacterial Panel EU (Catalog # 442963) due to foil bags containing extraction tubes that may not have been sealed properly. The affected product was distributed across multiple 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. Four specific lots are involved: #9085672, #9085673, #9106961, and #9106962, all with expiration dates between October 11, 2020 and November 2, 2020.

The source document does not specify what consumers or healthcare providers should do regarding 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: 994 units Lot/code info: Lot # 9085672; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085672(30)1; Exp:10/11/2020 Lot # 9085673; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085673(30)1; Exp:10/11/2020 Lot # 9106961; UDI (GTIN, DI+PI): (01)00382904429638 (17)201011(10)9106961(30)1; Exp:10/11/2020 Lot # 9106962; UDI (GTIN, DI+PI): (01)00382904429638 (17)201102(10)9106962(30)1; Exp:11/2/2020

Source

Official record: FDA (Device enforcement) ↗

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

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