Recalls / —

—#175107

Product

Kit BD Max Enteric Viral Panel EU Catalog # 443985

FDA product code

PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Device class

Class 2

Medical specialty

Microbiology

510(k) numbers

K181427

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Becton Dickinson & Co.

Address

7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated

2019-07-17

Terminated

2020-05-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.