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SD Biosensor, Inc. announced on Friday, May 5, that the company is requesting that consumers stop using “Pilot COVID-19 At-Home Tests” due to contaminants found in the tube with liquid inside, according to the Food and Drug Administration (FDA).
The affected tests can be identified by the lot number on the outer packaging (see below) and should be discarded in the trash. The liquid should never be poured down the drain.
Officials caution that exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness, though none have been reported to date.
If one does come into contact with the liquid or eyes, the FDA advises to flush with large amounts of water and if irritation persists, seek medical attention.
The at-home test kids were sold over-the-counter and use a nasal swap sample that can be self-collected and self-tested.
“Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube,” officials said.
“The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.”
They were distributed to CVS stores, online through Amazon. In total, more than 500,000 kits are subject to the recall.
Affected kits were distributed by Roche Diagnostics with these lot numbers, according to the FDA:
- 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;
- 53K42L2T1;
- 53K4361AC;
- 53K4362AC;
- 53K4392AC.
“The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk,” a release from the agency states. “The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.”
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