COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination
SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected 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 is an FDA Class I recall, which the rubric requires to score at minimum 4 (Severe). No illnesses or injuries have been reported, preventing a higher (Critical) classification.
Plain-English summary
SD Biosensor, Inc. is recalling Pilot COVID-19 At-Home Test kits (Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02) distributed nationwide due to bacterial contamination in the liquid buffer component. This recall affects 2,712,767 kits.
Users of affected test kits may notice a slight odor when the buffer is brought close to the nose. This odor indicates the presence of bacterial contamination.
The recall includes the following 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. Consumers with affected test kits should stop using them and contact SD Biosensor, Inc. or their retailer for replacement or refund options.
The recalled product
- Product
- Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
- Manufacturer
- SD Biosensor, Inc.
- Hazard
- Affected units
- 2,712,767
Distribution
Distributed nationwide across the United States.
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