Recall Z-1682-2023 ยท QMN Covid-19 Multi-Analyte Antigen Device
Becton Dickinson & Co.
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
| Date | Jun 2, 2023 (initiated May 1, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 Detecti |
| Quantity | 70,948 EA |
| Distribution | Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.