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Recall Observatory FDA recall evidence

Device product

Kit BD Max MRSA XT; Catalog # 443461

Z-2334-2019

July 17, 2019

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 83406
Status
Terminated
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-2334-2019

Official wording

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

Code information: Lot # 9106890; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200828(10)9106890(30)1; Exp :8/28/2020 Lot # 9106891; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200909(10)9106891(30)1; Exp :9/9/2020 Lot # 9114657; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200922(10)9114657(30)1; Exp : 9/22/2020

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.