North American Diagnostics: Medical Device Recall in 2022 - (Recall #: Z-1401-2022)

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:

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

Product Classification:

Class I

Date Initiated: June 15, 2022

Date Posted: August 10, 2022

Recall Number: Z-1401-2022

Event ID: 90381

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.

Status: Ongoing

Product Quantity: 122,366 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated