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Recall Observatory FDA recall evidence

Device product

Kit BD Max Vaginal Panel; Catalog # 443712

Z-2336-2019

July 17, 2019

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 83406
Status
Terminated
Classification
Class II
Quantity
666 units
Official record key
device-enforcement:Z-2336-2019

Official wording

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

Code information: Lot # 9092737; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092737(30)1; Exp : 3/21/2020 Lot # 9092738; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092738(30)1; Exp :3/21/2020 Lot # 9127920; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9127920(30)1; Exp : 3/21/2020

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.