NeuMoDx Molecular Inc: Medical Device Recall in 2022 - (Recall #: Z-1251-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 13, 2022

Date Posted: June 15, 2022

Recall Number: Z-1251-2022

Event ID: 90275

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.

Status: Ongoing

Product Quantity: 459 kits US; 1626 kits OUS

Code Information:

UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated