FDA recall Z-0195-2022

Product

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Reason for recall

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

Distribution

US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.

Key facts

Status

Terminated

Initiation date

2021-09-22

Report date

2021-11-10

Termination date

2022-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Walpole, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2022