FDA recall Z-1251-2022

Product

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

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.

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.

Key facts

Status

Ongoing

Initiation date

2022-05-13

Report date

2022-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2022