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Throw out These COVID-19 Tests Immediately

FDA says it has significant concerns of bacterial contamination in the liquid solution provided in certain at-home COVID-19 test kits distributed by Roche Diagnostics.

Amanda Pedersen

May 4, 2023

1 Min Read
Close up of woman swab COVID-19 testing by Rapid Antigen Test kit and dropping reagent to cartridge at home, Home Isolation,
Image credit: oatawa / iStock via Getty Images

Some Pilot COVID-19 at-home test kits may pose safety concerns due to bacterial contamination in the liquid solution that comes in the test kit, FDA warned Thursday afternoon.

Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test, the agency said. The test kits are distributed by Roche Diagnostics and manufactured by SD Biosensor.

SD Biosensor has initiated a recall for all impacted tests that Roche distributed to certain U.S. retailers. About 500,000 tests were distributed to CVS Health, and about 16,000 tests were distributed to Amazon. FDA said it is working with Roche Diagnostics to understand how many of those tests were sold to consumers.

Consumers who received their COVID-19 tests through the COVID.gov/tests distribution or as aprt of other federal testsing programs should be assured that their tests are not part of the recall, according to FDA.
However, if you have a Pilog COVID-19 test with the following lot numbers, you should throw the entire test kit in the trash. Do not pour the liquid solution down the drain, FDA said.

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

The agency also warns that if the liquid in the tube contacts your skin and eyes, you should flush with large amounts of water. If irritation persists, seek medical attention, FDA said. Anyone exposed to the contaminated liquid solution should also watch for signs of bacterial infection such as fever, discharge, red eyes, or any other concerning symptoms.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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