Recall Z-1594-2023— SD Biosensor, Inc.
Class I · Ongoing
Class I FDA medical device recall by SD Biosensor, Inc., initiated 2023-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728). Reason: 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..
- Recalling firm
- SD Biosensor, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-03-31
- Firm location
- Suwon, N/A, Korea (the Republic of)
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.