Elevated risk U.S. Food and Drug Administration

Pilot COVID-19 At-Home Test recall: Due to microbial contamination in the liquid buffer solution

Recall published 3+ years ago

Due to microbial contamination in the liquid buffer solution.

Pilot Medical devices — recalled medical devicesPilot Medical devices — recalled medical devices (photo 2)Pilot Medical devices — recalled medical devices (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
May 4, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Pilot
Product type
Medical devices
Reports of harm
To date, no such illness has been reported.

Products covered by this recall

COVID-19 At-Home Test

What the company announced

SEOUL, South Korea, May 4, 2023 /PRNewswire/ -- SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.

Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.

The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottest or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.

  • Lot Number: 53K38N1T1
  • Lot Number: 53K38N2T1
  • Lot Number: 53K38N3T1
  • Lot Number: 53K38N4T1
  • Lot Number: 53K38N5T1
  • Lot Number: 53K38P1T1
  • Lot Number: 53K38P2T1
  • Lot Number: 53K38P3T1
  • Lot Number: 53K41T5T1
  • Lot Number: 53K41X1T1
  • Lot Number: 53K41X2T1
  • Lot Number: 53K41X3T1
  • Lot Number: 53K4211T1
  • Lot Number: 53K4212T1
  • Lot Number: 53K4213T1
  • Lot Number: 53K4221T1
  • Lot Number: 53K4222T1
  • Lot Number: 53K4223T1
  • Lot Number: 53K4224T1
  • Lot Number: 53K4225T1
  • Lot Number: 53K4231T1
  • Lot Number: 53K4232T1
  • Lot Number: 53K4233T1
  • Lot Number: 53K4261T1
  • Lot Number: 53K4262T1
  • Lot Number: 53K4271T1
  • Lot Number: 53K4272T1
  • Lot Number: 53K4273T1
  • Lot Number: 53K4274T1
  • Lot Number: 53K4291T1
  • Lot Number: 53K4292T1
  • Lot Number: 53K42A1T1
  • Lot Number: 53K42A2T1
  • Lot Number: 53K42A3T1
  • Lot Number: 53K42E1T1
  • Lot Number: 53K42G1T1
  • Lot Number: 53K42G2T1
  • Lot Number: 53K42H1T1
  • Lot Number: 53K42H2T1
  • Lot Number: 53K42L1T1
  • Lot Number: 53K42L2T1
  • Lot Number: 53K4361AC
  • Lot Number: 53K4362AC
  • Lot Number: 53K4392AC

The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.

Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.

This request to discontinue use and dispose of the affected tests is currently isolated to specific lots of the Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, exclusively in the U.S. Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected.

You may report adverse events such as unexpected side effects or injury or product quality problems to the U.S. Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program in the following ways:

Online: Complete and submit a report on t his FDA webpage .

Standard mail or fax: Download this form or call 1-800-332-1088 to request a form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov) . This action is being taken with the knowledge of the FDA.

References

This product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

SOURCE SD Biosensor

FDA Safety Communication

COVID-19 Diagnostic Test

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 20 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 53K38N1T1
  • 53K38N2T1
  • 53K38N3T1
  • 53K38N4T1
  • 53K38N5T1
  • 53K38P1T1
  • 53K38P2T1
  • 53K38P3T1
  • 53K41T5T1
  • 53K41X1T1
  • 53K41X2T1
  • 53K41X3T1
  • 53K4211T1
  • 53K4212T1
  • 53K4213T1
  • 53K4221T1
  • 53K4222T1
  • 53K4223T1
  • 53K4224T1
  • 53K4225T1

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Pilot — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  3. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  4. Bag and bin it, or return it to the store for a refund.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: SEOUL, South Korea, May 4, 2023 /PRNewswire/ -- SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

Company contact: SD Biosensor, Inc. — Consumers: Roche Customer Support Center, 1-866-987-6243

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Pilot medical devices recalled?

Due to microbial contamination in the liquid buffer solution. Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 53K38N1T1, 53K38N2T1, 53K38N3T1. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: SEOUL, South Korea, May 4, 2023 /PRNewswire/ -- SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

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