BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, si

FDA device recall Z-1682-2023 · posted 2023-06-02 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment

Action taken

BD issued URGENT: Medical Device Product Correction Letter on 5/1/23 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: 1) Immediately inspect your inventory for the specific catalog and lot numbers listed in Attachment 1. 2) Ensure the contents of this Product Advisory are read and understood. 3) Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4) Please be advised the corrections noted above apply to the BD Veritor" System for Rapid Detection of SARS-CoV-2 & Flu A+B Instructions for Use (Part number 500051910, Revision 01 Date 2021-04 and eIFU Revision 02 Date 2022-01) immediately and will be present in future revisions. The current IFU version packaged with this test kit has not been authorized by FDA and customers should use the FDA-authorized Instructions For Use (IFU), BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B - Instructions for Use (https://www.fda.gov/media/147016/download), to perform the test. 5) Complete the attached Customer Response Form and return to the BD contact noted so that BD may acknowledge your receipt of this notification per FDA requirements. Actions Taken by BD: 1. BD is investigating root cause and will implement appropriate corrective and preventative measures to prevent reoccurrence. 2. The package insert Instructions for Use will be updated. BD Contact: US Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QMN

Quantity affected

70,948 EA

Distribution

Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.

Date initiated

2023-05-01

Date posted

2023-06-02

Location

Sparks, MD