Reported May 31, 2023 · Ongoing

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207…

SD Biosensor, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SD Biosensor, Inc. · 1556 Beon-Gil, Yeongtong · Suwon, N/A · N/A

Is this the product you have?

    • Pilot COVID-19 At-Home Test
    • Reference Number 9901-NCOV-10G
    • Catalog Number 99COV200L-EN02
  • UPC Code887473000207 (EAN-13: 08800111707728)
Lot codes and dates
  • Lot Numbers
    • 53K41T5T1
    • 53K41X1T1
    • 53K41X2T1
    • 53K41X3T1
    • 53K4211T1
    • 53K4212T1
    • 53K4213T1
    • 53K4221T1
    • 53K4222T1
    • 53K4223T1
    • 53K4224T1
    • 53K4225T1
    • 53K4231T1
    • 53K4232T1
    • 53K4233T1
    • 53K4261T1
    • 53K4262T1
    • 53K4271T1
    • 53K4272T1
    • 53K4273T1
    • 53K4274T1
    • 53K4291T1
    • 53K4292T1
    • 53K42A1T1
    • 53K42A2T1
    • 53K42A3T1
    • 53K42E1T1
    • 53K42G1T1
    • 53K42G2T1
    • 53K42H1T1
    • 53K42H2T1
    • 53K42L1T1
    • 53K42L2T1
    • 53K4361AC
    • 53K4362AC
    • 53K4392AC
    • 53K38N3T1
    • 53K38N2T1
    • 53K38N1T1
    • 53K38N4T1
    • 53K38N5T1
    • 53K38P1T1
    • 53K38P2T1
    • 53K38P3T1
Amount recalled
2,712,767 kits

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.