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U.S. Department of Health and Human Services

Class 2 Device Recall NeuMoDx Flu AB/RSV/SARSCoV2 Vantage Assay

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  Class 2 Device Recall NeuMoDx Flu AB/RSV/SARSCoV2 Vantage Assay see related information
Date Initiated by Firm January 21, 2022
Create Date March 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0738-2022
Recall Event ID 89675
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product 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.
Code Information Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Recalling Firm/
Manufacturer		 NeuMoDx Molecular Inc
1250 Eisenhower Pl
Ann Arbor MI 48108-3281
For Additional Information Contact QIAGEN Technical Services
800-362-7737
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or techservice-na@qiagen.com.
Quantity in Commerce 102 boxes
Distribution US Nationwide distribution in the states of FL, MD, MI, NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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