Device product

Kit BD Max ExK DNA 1 USA; Catalog # 442817

Z-2323-2019

July 17, 2019

Class II

Product summary

Firm: Becton Dickinson & Co.
Event: Event 83406
Status: Terminated
Classification: Class II
Quantity: 115 units
Official record key: device-enforcement:Z-2323-2019

Official wording

Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information: 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

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.