Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Reported: May 31, 2023 Initiated: March 31, 2023 #Z-1594-2023
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.
Details
- Recalling Firm
- SD Biosensor, Inc.
- Units Affected
- 2,712,767 kits
- Distribution
- US Nationwide.
- Location
- Suwon, N/A
Frequently Asked Questions
What product was recalled? ▼
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728). Recalled by SD Biosensor, Inc.. Units affected: 2,712,767 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2023. Severity: Critical. Recall number: Z-1594-2023.
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