SD Biosensor, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0719-2022)

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:

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

Product Classification:

Class I

Date Initiated: January 31, 2022

Date Posted: March 23, 2022

Recall Number: Z-0719-2022

Event ID: 89527

Reason for Recall:

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Status: Ongoing

Product Quantity: ~400,000 kits

Code Information:

REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)

Distribution Pattern:

U.S. Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated