Z-1251-2022Class II

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

Name: Z-1251-2022 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Creator: NeuMoDx Molecular Inc
Published: 2022-05-13
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2022-05-13 / Open, Classified / root cause: manufacturing process

FDA source

NeuMoDx Molecular Inc began a recall of NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 on 2022-05-13. FDA classified it as Class II and gives the reason as "There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1251-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-13
Posted: 2022-06-08
Recalling firm: Neumodx Molecular, Inc.
Product: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 13, 2022, the firm distributed Urgent Medical Device Correction letters to impacted customers. The letter informed customers of the reduced analytical sensitivity for Flu A, SARS-CoV-2, and RSV. The firm also specified that only the RSV target showed a similar reduction in clinical sensitivity; Influenza A and SARS-CoV-2 did not show a reduction in clinical sensitivity. Influenza B is not affected by this issue. The letter reminded users that negative results do not preclude infection with Influenza virus, RSV, and/or SARS-CoV-2, and the device should not be used as the sole basis for patient management and treatment decisions. Customers should share the notice with all affected users. If you have any questions regarding this recall, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected].
Quantity in commerce: 459 kits US; 1626 kits OUS
Distribution: Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
Product codes and lots: UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-08

Product code QLT

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)