NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 a
Summary
The FDA issued a Class II for NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under by NeuMoDx Molecular Inc. Reason: A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive r.
Details
Source
Device Recall
External ID
Z-0738-2022
Action Date
2022-03-16
Status
Ongoing
Category
device
Product Description
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Lot/Code Info: Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Quantity Affected: 102 boxes
Reason for Recall
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Distribution
US Nationwide distribution in the states of FL, MD, MI, NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-21
Company
Ann Arbor, MI
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 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NeuMoDx Molecular Inc has 7 FDA actions in our database, including 6 recalls and 1 clearance.
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 (NeuMoDx Molecular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NeuMoDx Molecular Inc have FDA actions?
NeuMoDx Molecular Inc has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0738-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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