SD Biosensor, Inc. announced Friday, May 5 that, according to the U.S. Food and Drug Administration, the company is asking consumers to stop using the “Pilot COVID-19 At-Home Tests” because contaminants (Food and Drug Administration).
Affected tests can be identified by the batch number on the outer packaging (see below) and should be disposed of in the trash. Never pour liquid down the drain.
Officials have warned that serious illness could result from exposure to the fluid in the tube due to misuse or spillage, although nothing has been reported so far.
If contact with liquid or eyes does occur, FDA recommends flushing with plenty of water and seeking medical attention if irritation persists.
The at-home test for kids is sold over the counter using a nasal exchange sample that can be self-collected and self-tested.
“Individuals performing the self-test may be risking direct contact with the contaminated fluid in the test tube,” officials said.
“The liquid is contained in a single, ready-to-use, pre-filled and sealed tube, but when opening the tube or disposing of an open tube or performing a test, the user may inadvertently come into direct contact with the contaminated liquid”
They are distributed online through Amazon to CVS stores. In total, more than 500,000 kits are subject to recall.
According to the FDA, the affected kits were distributed by Roche Diagnostics with the following lot numbers:
- 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.
“FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is categorizing the recall risk,” a release from agency country. “The FDA is continuing to work with SD Biosensor Inc. to evaluate the company’s corrective actions to address the cause of the bacterial contamination and to help ensure that the situation is resolved so that it does not recur.”
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