500,000+ COVID-19 Home Tests Have Been Recalled By the FDA


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Federal health safety officials are recalling more than half a million rapid-antigen COVID-19 tests due to evidence that suggests they may be tainted by harmful bacteria. Designed to help users determine if they have been infected by SARS-CoV-2 (the virus that leads to COVID-19), these recalled tests may pose a threat of fever, nausea and abdominal pain, among other bacterial infection symptoms — especially for immunocompromised Americans.

Current recall notices published by the Food and Drug Administration (FDA) indicate that impacted COVID-19 tests must be disposed of immediately, as bacterial organisms like Enterococcus, Enterobacter, Serratia species and Klebsiella potentially have contaminated materials. While the agency has yet to receive any reports of illness, injuries or death associated with COVID-19 testing kits, bacterial infections caused by this potential contamination can cause illness and more serious risks for those with underlying medical conditions.

Made by SD Biosensor, Inc., a bulk of the recalled rapid antigen COVID-19 tests — sold as Pilot COVID-19 At-Home Tests, and distributed by Roche Diagnostics — were sent to CVS Health retailers. Another 16,000 recalled tests were distributed to Amazon, though both Roche Diagnostics and FDA officials are currently unsure of how many test kits were eventually sold to consumers.

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Read on to learn more about this recall and how to identify if your COVID-19 rapid home tests are included, plus how to properly dispose of them.

FDA recall on rapid COVID-19 tests

SD Biosensor, Inc. and Roche Diagnostics launched a voluntary recall on May 4 in conjunction with the FDA, which includes over half a million units distributed nationwide, according to the official recall listing. The manufacturer shared that they first discovered the potential contamination during what they say was a “routine quality assurance testing.”

While no illnesses or deaths have been reported so far, FDA officials note they are “currently reviewing” the scope of the recall and are “in the process of classifying the recall risk.”

The recall centers on potential bacterial contamination that likely affects the pre-filled, sealed and ready-to-use liquid solution used in conducting a rapid home COVID-19 test. Meaning, if following directions correctly, most users wouldn’t come into direct contact with the liquid given that it’s used to prepare a nasal sample for testing. “A user may inadvertently come in direct contact with contaminated liquid buffer during opening the tube or handling of the open tube or while performing the test,” FDA officials note.

If used incorrectly, though, signs of bacterial infection (including fever and red, irritated eyes) may appear after coming into contact with tainted test materials. And FDA officials advise Americans to flush with water and seek medical attention if liquid in the test tube comes into contact with the skin or your eyes.

A full list of FDA-recalled home Pilot COVID-19 At-Home tests

While only a single product is being recalled, there are more than 40 lot codes — a unique string of numbers and characters that allow manufacturers to trace these products — currently included as part of the Pilot COVID-19 At-Home Test recall. These impacted lot codes, which are printed on the front panel of the box near its product barcode and manufacturing date, are shared in full within the FDA’s recall listing.

You may also manually check to see if your Pilot COVID-19 At-Home Test is included in current recalls with Roche Diagnostics’ interactive search tool on its recall website for impacted customers. Those who have potentially contaminated testing kits are being directed to throw the entire product into the trash directly; the liquid solution should remain unopened, so don’t pour it down a drain.

You’ll find a full list of impacted lot codes associated with the Pilot COVID-19 At-Home Test recall below:

  • 53K38N1T1
  • 53K38N2T1
  • 53K38N3T1
  • 53K38N4T1
  • 53K38N5T1
  • 53K38P1T1
  • 53K4231T1
  • 53K42G1T1
  • 53K4221T1
  • 53K4292T1
  • 53K4222T1
  • 53K42A1T1
  • 53K4223T1
  • 53K42A2T1
  • 53K4224T1
  • 53K42A3T1
  • 53K4225T1
  • 53K42E1T1
  • 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

Those who have confirmed their Pilot COVID-19 At-Home Test contains an affected lot code can request a free replacement from Roche Diagnostics by filling out a mail-order request form, or by calling 1-866-987-6243 and selecting option 1. It’s unclear how long replacements will take to reach impacted customers at this time.

It’s important to note that not every single Pilot COVID-19 At-Home Test currently on the market is included in this recall, meaning you may have a Pilot product currently that is still safe to use. None of the impacted home tests were distributed through free federal testing programs, according to the FDA, meaning any tests you’ve stockpiled through this recently terminated program should still be safe for use provided they have not expired.

Impact on test performance

According to the FDA, in addition to risk of bacterial infection, a false-negative or false-positive result may be possible if you used a recalled testing kit product. Federal health agents are instructing healthcare providers to retest patients that have symptoms if a Pilot COVID-19 At-Home Test was used within two weeks, in case of inaccurate results. It’s important to re-test yourself as soon as possible to prevent spreading COVID-19 unknowingly.

Health Editor

Zee Krstic is a health editor for Good Housekeeping, where he covers health and nutrition news, decodes diet and fitness trends and reviews the best products in the wellness aisle. Prior to joining GH in 2019, Zee fostered a nutrition background as an editor at Cooking Light and is continually developing his grasp of holistic health through collaboration with leading academic experts and clinical care providers. He has written about food and dining for Time, among other publications.





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