Kit BD Max StaphSR; Catalog # 443419
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling the BD Max StaphSR Kit (Catalog # 443419) because foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. A total of 207 units across two lots (Lot # 9086668 and Lot # 9092724, both expiring 9/2/2020) were affected and distributed to multiple U.S. states and countries worldwide including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
The source document does not specify a remedy or instructions for consumers who may have this product.
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: 207 units Lot/code info: Lot # 9086668; ; UDI (GTIN, DI+PI) : (01)00382904434199 (17)200902(10)9086668(30)1; Exp :9/2/2020 Lot # 9092724; UDI (GTIN, DI+PI) :(01)00382904434199 (17)200902(10)9092724(30)1; Exp: 9/2/2020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.