FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
- Recall number
- Z-2324-2019
- Recalling firm
- Becton Dickinson & Co.
- Product
- Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
- Status
- Terminated
- Initiated
- 2019-07-17
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 447 units
- 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
- Lot, serial or model codes
- Lot# 9085668; UDI (GTIN, DI+PI):(01)00382904428181 (17)201024(10)9085668(30)1; Exp:10/24/2020 Lot # 9106887; UDI (GTIN, DI+PI):(01)00382904428181 (17)201107(10)9106887(30)1; Exp: 11/7/2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28