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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 17, 2019
Create Date August 22, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-2339-2019
Recall Event ID 83406
510(K)Number K181427  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product Kit BD Max Enteric Viral Panel EU
Catalog # 443985
Code Information Lot # 9085674; UDI (GTIN, DI+PI): (01)00382904439859 (17)201101(10)9085674(30)1; Exp: 11/1/2020  Lot # 9107980; UDI (GTIN, DI+PI): (01)00382904439859 (17)201107(10)9107980(30)1; Exp: 11/7/2020 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Customer/Technical Support
800-638-8663
Manufacturer Reason
for Recall		 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
FDA Determined
Cause 2		 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 in Commerce 469 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PCH and Original Applicant = Becton, Dickinson and Company
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