Kit BD Max ExK DNA 1 USA; Catalog # 442817
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling the BD Max ExK DNA 1 USA kit (Catalog # 442817) because foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. A total of 115 units across three lots were affected: Lot #9085666 (expiration 10/24/2020), Lot #9106886 (expiration 11/7/2020), and Lot #9127935 (expiration 11/30/2020). The recalled product was distributed to all U.S. states and territories, as well as internationally to Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
The recall record does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
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: 115 units Lot/code info: Lot # 9085666; UDI (GTIN, DI+PI): (01)00382904428174 (17)201024(10)9085666(30)1; Exp: 10/24/2020 Lot #9106886; UDI (GTIN, DI+PI): (01)00382904428174 (17)201107(10)9106886(30)11; Exp: 11/7/2020 Lot #9127935; UDI (GTIN, DI+PI): (01)00382904428174 (17)201130(10)9127935(30)11; Exp: 11/30/2020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.