SD Biosensor recalls Pilot COVID-19 At-Home Test kits with bacterial contamination in liquid buffer. Affected lots may have a slight odor when buffer is near nose. Consumers should stop using these specific lots.
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
SD Biosensor is recalling Pilot COVID-19 At-Home Test kits that contain bacterial contamination in the liquid buffer. Users may notice a slight odor when the buffer is brought close to their nose. This could lead to inaccurate test results or potential health risks.
The liquid buffer in the affected test kits contains bacteria. When users bring the buffer close to their nose, they may detect a slight odor. This contamination could lead to inaccurate test results or potential health risks if the bacteria are inhaled or come into contact with the user.
Anyone who purchased the Pilot COVID-19 At-Home Test kits with the specific lot numbers listed in the recall. People using these kits for home testing are most at risk if they notice a slight odor from the buffer.
Check the lot numbers on the test kit packaging: 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, 53K38N3T1, 53K38N2T1, 53K38N1T1, 53K38N4T1, 53K38N5T1, 53K38P1T1, 53K38P2T1, 53K38P3T1. The product has a UPC code of 887473000207.
Look for the specific lot numbers listed in the recall on the test kit packaging.
If you have the affected lot numbers, stop using these test kits immediately.
The liquid buffer in the affected test kits contains bacteria. Users may notice a slight odor when the buffer is brought close to their nose.
Check the lot numbers on the test kit packaging: 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, 53K38N3T1, 53K38N2T1, 53K38N1T1, 53K38N4T1, 53K38N5T1, 53K38P1T1, 53K38P2T1, 53K38P3T1.
Stop using the affected test kits immediately and check the lot numbers on the packaging.
We’ve drafted a message you can send SD Biosensor to request your refund or repair — edit it as you like.
Subject: Recall Z-1594-2023 — SD Biosensor SD Biosensor Hello, I own a SD Biosensor that is covered by recall Z-1594-2023 from SD Biosensor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
