Do not use: FDA issues warning about recalled COVID-19 tests due to bacterial contamination

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(WHTM) — The U.S. Food and Drug Administration issued a safety warning against the use of some recalled at-home COVID-19 tests.

The FDA says SD Biosensor Inc. Pilot COVID-19 at-home tests, which are distributed by Roche Diagnostics, have been recalled over concerns of bacterial contamination in the liquid solution that comes in the test kits. The FDA is urging both consumers and health care providers to stop using the affected tests.

According to the FDA, direct contact with the contaminated liquid could pose a safety concern such as possible skin irritation or bacterial infection. The contamination could also affect the performance of the test, including potentially false results, the FDA says.

None of the impacted tests were distributed through the U.S. government’s Free at Home COVID-19 tests program.

Around 500,000 of the recalled tests were distributed to CVS Health, and around 16,000 went to Amazon. The FDA and Roche Diagnostics are working together to determine how many were sold to consumers.

Courtesy of SD Biosensor, Inc.

The FDA provided lot numbers of tests affected by the possible contamination:

53K38N1T1 53K4221T1 53K4292T1
53K38N2T1 53K4222T1 53K42A1T1
53K38N3T1 53K4223T1 53K42A2T1
53K38N4T1 53K4224T1 53K42A3T1
53K38N5T1 53K4225T1 53K42E1T1
53K38P1T1 53K4231T1 53K42G1T1
53K38P2T1 53K4232T1 53K42G2T1
53K38P3T1 53K4233T1 53K42H1T1
53K41T5T1 53K4261T1 53K42H2T1
53K41X1T1 53K4262T1 53K42L1T1
53K41X2T 53K4271T1 53K42L2T1
53K41X3T1 53K4272T1 53K4361AC
53K4211T1 53K4273T1 53K4362AC
53K4212T1 53K4274T1 53K4392AC
53K4213T1 53K4291T1  
Courtesy of the FDA

The FDA is advising people with tests bearing the above lot numbers to throw the whole test kit in the “household trash” and not to pour the liquid down the drain. If the liquid comes into contact with your skin or eyes, you should thoroughly flush with lots of water.

The FDA also urges people to watch for signs of bacterial infection, such as fever, discharge, red eyes or other potential symptoms. If signs emerge, get medical attention.

Anyone with questions can email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

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