COVID test recall alert: Some Pilot At-Home Tests contaminated
About 500,000 of the recalled COVID tests were distributed to CVS Health and about 16,000 were sent to Amazon for sale.
WASHINGTON — More than half a million home COVID-19 tests are being recalled due to potentially harmful bacteria found in liquid solutions.
SD Biosensor, Inc. announced a recall this week of more than 40 lots of the company’s over-the-counter COVID-19 home test kits.
Although the specific number of the recalled tests was not released, according to the US Food and Drug Administration, about 500,000 were distributed to CVS Health and about 16,000 were sent to Amazon for sale. The FDA said it is working with the company to determine how many of the recalled COVID test kits have been sold.
The FDA emphasized that none of the recalled batches were distributed through federal testing programs or through COVID.gov.
Affected tests can be identified by the batch number on the outer packaging and should be disposed of in the trash. If you have one of the recalled tests, you must not pour the liquid down any household drain.
According to the recall notice, potentially harmful bacteria were found in a test tube with liquid inside (bag 2 of the kit). It notes that although the liquid is contained in a sealed tube, direct contact with the liquid due to misuse or spillage can lead to serious illness.
In addition, the FDA says contamination can affect test performance and cause false-negative or false-positive results.
Consumers can view the full list of recalled lots below or look up the test kit’s lot number on this website, which will indicate whether a particular test kit can be used. properly handled.
Consumers can also contact the Roche Customer Support Center at 1-866-987-6243 and select option 1. If the consumer test kit comes from an unaffected shipment, then it is safe to continue using the test from that kit according to the instructions for use, which can be found in the test kit or at go.roche.com/covid-home-test.
The lots included in the recall are:
- 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
