BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
- Company
- Becton Dickinson & Co.
- Recall Initiated
- May 1, 2023
- Posted
- June 2, 2023
- Recall Number
- Z-1682-2023
- Quantity
- 70,948 EA
- Firm Location
- Sparks, MD
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
Distribution
Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
Lot / Code Info
UDI-DI: N/A Lot Number Expiration Date 2077698 01-06-23; 2077708 05-06-23; 2209447 05-11-23; 2209462 09-11-23; 2212158 09-11-23; 2241596 09-11-23; 2242261 12-11-23; 2259433 15-11-23; 2259612 12-11-23; 2283876 10-01-24; 2332350 01-02-24; 2332352 07-03-24; 2340087 15-03-24; 2340090 16-03-24; 2348229 17-03-24; 2348238 22-03-24; 2348241 22-03-24; 2364051 10-04-24; 3003941 12-04-24; 3004372 14-04-24; 3009033 16-04-24; 3009036 16-04-24; 3009093 16-04-24; 3009985 16-04-24
Root Cause
Under Investigation by firm
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