RecallRadar

FDA Device recall Z-2326-2019

Kit BD Max ExK DNA 2 EU LUO

On 2019-08-28 the FDA classified a Class II recall of Kit BD Max ExK DNA 2 EU LUO by Becton Dickinson And, citing the foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2326-2019
ClassificationClass II
Statusterminated
Initiated2019-07-17
Published2019-08-28
Last updated2026-09-13 11:55 UTC
CompanyBecton Dickinson And
DistributionAL, 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

Product

Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

Reason

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

Identifiers

code_infoLot # 9114655; UDI (GTIN, DI+PI): (01)00382904428204 (17)201107(10)9114655(30)1; Exp:11/7/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2019%22

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