Jiangsu Well Biotech COVID-19 test kits distributed without FDA authorization
Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall carries an FDA Class I classification, which applies to medical devices presenting reasonable probability of serious adverse health consequences. However, the source documents no reported illnesses, injuries, or documented test failures. The recall is based on regulatory non-compliance (unauthorized distribution) rather than confirmed safety issues.
Plain-English summary
Jiangsu Well Biotech Co., Ltd. distributed approximately 620,000 COVID-19 Ag Rapid Test Devices (catalog number CO-02, also marketed as SDI LABS) in the United States without obtaining FDA Emergency Use Authorization, Pre-Market Approval, or Clearance. This distribution violates federal requirements for medical devices.
The affected test kits were distributed in California, with additional distribution locations pending identification by the manufacturer. The recalled lot numbers include: 202107192, 202108231, 202109231, 202111082, 202110111, and 202201102.
Consumers should not use these test devices. Anyone who has used these devices for COVID-19 testing should consult their healthcare provider if they have questions about the accuracy or reliability of their results. Healthcare providers and clinical laboratories should verify that only FDA-authorized or cleared COVID-19 tests are in use.
The recalled product
- Product
- Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Manufacturer
- Jiangsu Well Biotech Co.,Ltd.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 620,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192
- 202108231
- 202109231
- 202111082
- 202110111
- 202201102
Distribution
Distributed in 1 state:
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