Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could affect test results.
SD Biosensor Inc. has recalled all affected tests distributed to certain retailers in the U.S. Approximately 500,000 tests were distributed to CVS Health, and about 16,000 to Amazon. The FDA is working with test distributor Roche Diagnostics to find out how many of those tests were sold to consumers.
None of the affected lots were distributed through federal testing programs.
The FDA is advising consumers to stop using and throw out Pilot COVID-19 at-home test kits with the following lot numbers:
| 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 |
If your SD Biosensor Pilot COVID-19 at-home test is included in the recall, do not use it and throw out the entire kit in the household trash. Do not pour the liquid solution down the drain.
Talk to your health care provider if you think you were tested with a test under recall or if you have concerns about your test results.
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