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Kit BD Max ExK DNA 1 USA recallZ-2323-2019 · Becton Dickinson & Co. · initiated Jul 17, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

1. Thoroughly inspect all foil bags prior to use. If any of the foil bags in your inventory contain holes, dispose of the product and note the quantity in the attached Customer Response Form in order to request replacement. 2. Even if you do not have inventory of the product listed, complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 3. Share this Advisory Letter with all users of the BD MAX instrument within your facility to ensure awareness. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDAs MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 BD Customer/Technical Support, 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.

Recall details

Recall number
Z-2323-2019
Status
Terminated
Initiated by the company
Jul 17, 2019
Recalling firm
Becton Dickinson & Co.
Quantity
115 units
Product code
JJH
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

Product description

Kit BD Max ExK DNA 1 USA; Catalog # 442817

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 83406).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page