Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling 130 units of the BD Max Check-Points CPO IVD EU kit (Catalog # 278102, Lot # 9114645) because the foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. The affected product was distributed across numerous U.S. states including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia, as well as internationally to Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
The source document does not specify a remedy or describe what actions affected consumers should take 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: 130 units Lot/code info: Lot # 9114645; UDI (GTIN, DI+PI): (01)00180002781029 (17)200719(10)9114645(30)1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.