Z-0738-2022Class II

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in...

Name: Z-0738-2022 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in...
Creator: NeuMoDx Molecular Inc
Published: 2022-01-21
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2022-01-21 / Open, Classified

FDA source

NeuMoDx Molecular Inc began a recall of 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... on 2022-01-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0738-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-21
Posted: 2022-03-08
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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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 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 [email protected].
Quantity in commerce: 102 boxes
Distribution: US Nationwide distribution in the states of FL, MD, MI, NY.
Product codes and lots: Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0738-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-08

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)