Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1594-2023 — Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

U.S. FDA — Device Enforcement · Korea (the Republic of) · 2023-03-31 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1594-2023
Date of alert
2023-03-31
Country / jurisdiction
Korea (the Republic of)
Risk level
Class I
Risk type
recall
Brand
SD Biosensor, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
887473000207
Reported risk: The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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