Pilot COVID-19 At-Home Test — Class I medical device recall Z-1594-2023
Ongoing recall by SD Biosensor, Inc., reported 2023-05-31, distributed nationwide. The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User
| Recall number | Z-1594-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SD Biosensor, Inc., Suwon, N/A, Korea (the Republic of) |
| Recall initiated | 2023-03-31 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 2,712,767 kits |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00887473000207, 08800111707728 |
| Lot numbers | 53K38N1T1, 53K38N2T1, 53K38N3T1, 53K38N4T1, 53K38N5T1, 53K38P1T1, 53K38P2T1, 53K38P3T1, 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 and 4 more |
| Model numbers | 99COV200L-EN02 |
Product
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1594-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.