Lower risk Medical device recall · FDA · Published March 31, 2023

SD Biosensor Pilot COVID-19 At-Home Test Recall: Bacterial Contamination Risk

SD Biosensor recalls Pilot COVID-19 At-Home Test kits with bacterial contamination in liquid buffer. Affected lots may have a slight odor when buffer is near nose. Consumers should stop using these specific lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1594-2023Medical device SD Biosensor ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSD Biosensor, Inc.1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero · Suwon, Korea (the Republic of)

✎ GovInfoNow plain-language explainer

SD Biosensor is recalling Pilot COVID-19 At-Home Test kits that contain bacterial contamination in the liquid buffer. Users may notice a slight odor when the buffer is brought close to their nose. This could lead to inaccurate test results or potential health risks. Read more at govinfonow.com/recall/58629-sd-biosensor-pilot-covid-19-at-home-test-recall-bacterial.

Source Summary by GovInfoNow · govinfonow.com/recall/58629-sd-biosensor-pilot-covid-19-at-home-test-recall-bacterial · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1594-2023

Cite this page

“SD Biosensor Pilot COVID-19 At-Home Test Recall: Bacterial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58629-sd-biosensor-pilot-covid-19-at-home-test-recall-bacterial. Based on FDA recall #Z-1594-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1594-2023%22&limit=1).

The FDA announced on March 31, 2023, that SD Biosensor, Inc. is recalling Pilot COVID-19 At-Home Tests due to bacterial contamination in the liquid buffer component. Owners should contact the company for a full refund.

How to tell if you have it

Brand: SD Biosensor
Product: Pilot COVID-19 At-Home Test
Reference Number: 9901-NCOV-10G
Catalog Number: 99COV200L-EN02
UPC Code: 887473000207
EAN-13: 08800111707728
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
Units affected: 2,712,767 kits

The hazard

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. Users may notice a slight odor when the buffer is brought close to the nose.

Context

GovInfoNow's records show SD Biosensor, Inc. has one other recall on record since Jan. 31, 2022, for STANDARD Q COVID-19 Ag Home Test kits not approved for U.S. use. Other recent recalls of similar products include Instrumentation Laboratory Coagulation Test Kits Risk Microbial Contamination (Dec. 11, 2025), BioFire Respiratory Panel 2.1 Recall: False Negatives Risk (Oct. 22, 2025), and Meridian Bioscience Revogene C. difficile Test Recall: False-Negative Risk (Dec. 5, 2025).

How to tell if you have this one

Check the lot numbers on the test kit packaging: 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. The product has a UPC code of 887473000207.

Brand
SD Biosensor
Product
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Look for the specific lot numbers listed in the recall on the test kit packaging.
Stop Using Affected Kits
If you have the affected lot numbers, stop using these test kits immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 31, 2023Firm started the recall
May 23, 2023FDA classified it Class I
May 31, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More SD Biosensor recalls

Link to this recall

<a href="https://govinfonow.com/recall/58629-sd-biosensor-pilot-covid-19-at-home-test-recall-bacterial">SD Biosensor Pilot COVID-19 At-Home Test Recall: Bacterial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1594-2023 (March 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1594-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.