FDA Medical Device Recalls (openFDA)
NeuMoDx Molecular Inc: 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.
- Recall number
- Z-0738-2022
- Recalling firm
- NeuMoDx Molecular Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2022-01-21
- Posted
- not on file
- Terminated
- not on file
- 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 results when using the product.
- Root cause
- 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
- 102 boxes
- Distribution
- US Nationwide distribution in the states of FL, MD, MI, NY.
- Lot, serial or model codes
- Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3010729479
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28