BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, s
Summary
The FDA issued a Class II for BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Tes by Becton Dickinson & Co.. 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 b.
Details
Source
Device Recall
External ID
Z-1682-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
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
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
Quantity Affected: 70,948 EA
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-01
Company
Sparks, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1682-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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