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Z-0719-2022 Class I Ongoing

Recalled by SD Biosensor, Inc. — Suwon, N/A

Recall Details

Product Type: Devices
Report Date: March 23, 2022
Initiation Date: January 31, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: ~400,000 kits

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.

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.

Distribution Pattern

U.S. Nationwide Distribution

Code Information

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