Home / Recalls / North American Diagnostics / Z-1401-2022

Z-1401-2022 Class I Ongoing

Recalled by North American Diagnostics — Holly Hill, FL

Recall Details

Product Type: Devices
Report Date: August 10, 2022
Initiation Date: June 15, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 122,366 units

Product Description

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 Pattern

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.

Code Information

Lot: FLUSA 1020-1, Batches 8, 10, and 12