FDA recall Z-1401-2022

Product

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

Reason for recall

Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.

Key facts

Status

Ongoing

Initiation date

2022-06-15

Report date

2022-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Holly Hill, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1401-2022