Kit BD Max StaphSR; Catalog # 443418
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling 283 units of BD MAX StaphSR Kit (Catalog # 443418) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected product includes two lots: Lot # 9086668 and Lot # 9092724, both with an expiration date of September 2, 2020. The recalled kits were distributed across numerous U.S. states 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 instructions for consumers who may have affected units.
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: 283 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.