What You Need to Know About the Pilot COVID-19 At-Home Test Recall

Understand buffer contamination and follow safe disposal steps to protect your health.

By Medha deb

Created on Sep 22, 2025

Understand buffer contamination and follow safe disposal steps to protect your health.

Pilot COVID-19 At-Home Test Recall: What Consumers Need to Know

The FDA issued a Class I recall for certain Pilot COVID-19 At-Home Test kits due to concerns over bacterial contamination in the liquid buffer, presenting serious health risks. This article covers the reasons behind the recall, potential dangers, actions recommended for consumers, and guidance on safe test disposal.

Background: Why Was the Pilot COVID-19 Test Recalled?

In March 2023, SD Biosensor Inc.—the manufacturer of the Pilot COVID-19 At-Home Test—initiated a recall of approximately 2.7 million test kits distributed throughout the United States. This decision came after bacterial contamination was detected in the liquid buffer component of certain lots of the at-home test kits. The FDA classified this as a Class I recall: the most serious type, indicating that using the affected products could cause severe health consequences or even death.

For those navigating the complexities of recalls, understanding consumer safety measures is crucial. Rely on our detailed consumer guide for Bayer's Alka-Seltzer Plus Recall to better comprehend related health risks and the necessary actions to safeguard your well-being.

Recall initiated by SD Biosensor Inc. on March 31, 2023
FDA posted recall May 23, 2023
Bacterial contamination specifically found in the liquid buffer solution of test kit lots
Consumers were advised to stop using the affected kits and discard them

What is a Class I Recall?

A Class I recall represents the FDA’s highest level of product recall, reserved for situations where use of a medical device could lead to significant injury or death. This underscores the seriousness of the problem with the recalled Pilot COVID-19 At-Home Test lots.

Details of the Recall: Affected Products and Manufacturer

The recall impacts the Pilot COVID-19 At-Home Test, which is an antigen detection kit used for self-testing suspected cases of COVID-19 at home. Below are the specific identification details for the affected product:

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Product Name: Pilot COVID-19 At-Home Test
Reference Number: 9901-NCOV-10G
Catalog Number: 99COV200L-EN02
UPC Code: 887473000207 (EAN-13: 08800111707728)
Manufacturer: SD Biosensor, Inc. (Suwon, Korea, Republic of)

The affected test kits were distributed in the United States between September 2022 and November 2022. In total, an estimated 2,712,767 kits were distributed nationwide before the recall was initiated.

Key Dates for the Recall

Date Recall Initiated: March 31, 2023
Date Recall Announced/Publicized: May 4, 2023 (Press Release); May 23, 2023 (FDA Notification)

Why Was the Recall Issued? The Problem with the Liquid Buffer

The recall was a result of confirmed bacterial contamination within the liquid buffer solution included in certain test kit lots. The buffer is a crucial part of the test, as it is used to extract and detect the coronavirus antigen from patient samples.

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SD Biosensor Inc. determined that some lots of the buffer contained bacteria, making their use unsafe. The FDA found that this contamination could pose significant health risks, especially for vulnerable groups.

Source of contamination: Material/Component Contamination of the buffer solution
Noted consumer warning: Some users might detect a slight odor if buffer is brought near the nose

Health Risks Linked to Contaminated Buffer

The main health concern associated with a contaminated buffer is the risk of infection. If the liquid comes into contact with skin, eyes, or is accidentally ingested, it can cause serious illness. People with weakened immune systems, the elderly, and those with chronic illnesses are considered especially at risk.

Understanding the potential dangers of related products is key. Make sure to check our expanded recall information on DermariRe hand soap and sanitizer to safeguard your health against similar bacterial contamination issues.

Potential symptoms of infection: Fever, redness, swelling, pain at site of contact, or more severe systemic infection if ingested or absorbed
Greater risk for immunocompromised individuals, children, and elderly adults

What Should Consumers Do If They Have the Recalled Test?

The FDA and manufacturer instructed consumers and healthcare providers to take the following steps if they possess any of the affected Pilot COVID-19 At-Home Test kits:

Do NOT use the recalled test kit.
Dispose of the test kit safely in household trash. Do not flush or pour the buffer down a sink or toilet.
If the liquid buffer solution was spilled on skin, clothing, or surfaces, wash the area with soap and water immediately. For eye exposure, rinse thoroughly with water and seek medical attention if necessary.
If you develop symptoms of infection after contact, contact your healthcare provider right away.
Contact Roche Support: If you have the recalled test or need guidance, call their customer support at 1-866-987-6243 (option 1).

To stay ahead of potential health risks, familiarize yourself with various product recalls. Check out our comprehensive list of Eye Drops Recalls for 2023–2024 to know what to avoid and how to protect your eyes effectively.

How to Identify the Recalled Test Kits

Check your COVID-19 Self-Test supply at home for any kits labeled as “Pilot COVID-19 At-Home Test.” To be certain, look for the following on the test packaging:

Pilot COVID-19 At-Home Test logo
Reference number: 9901-NCOV-10G
Catalog number: 99COV200L-EN02
UPC Code: 887473000207; EAN-13: 08800111707728
Expiration date (all lots have now expired as of 2024)

If you are unsure about your kit, check the FDA’s official recall information or reach out to Roche Support for confirmation.

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Affected Lot Numbers

The recall affected multiple lot numbers. For a detailed list of affected lot numbers, the manufacturer instructs consumers to visit their informational resource or contact customer support directly.

What to Do If You’ve Already Used a Recalled Kit

If you have used a recalled Pilot COVID-19 test, monitor for signs of infection or illness such as fever, redness, or pain, particularly at points where buffer solution could have contacted your skin, eyes, or mouth.

If you show symptoms, contact your healthcare provider immediately.
Inform your provider that you used a recalled test possibly affected by bacterial contamination.

Impact and Scope of the Recall

The recall represents a substantial safety initiative, as approximately 2.7 million test kits were distributed US-wide prior to the recall. The FDA continues to monitor the situation, providing updates as the recall progresses and further corrective actions are taken.

**Pilot COVID-19 At-Home Test Recall – Summary Table**
Recall Aspect	Details
Manufacturer	SD Biosensor, Inc.
Date Recall Initiated	March 31, 2023
Recall Classification	Class I (Serious risk of harm)
Reason for Recall	Bacterial contamination in buffer solution
Products Distributed	2,712,767 kits
Distribution Area	US Nationwide
Status	Open, under FDA monitoring

What Happens to the Recalled Kits?

Consumers are asked to dispose of the recalled tests in their regular household trash, following basic safety precautions to avoid any contact with the liquid buffer. Additionally, retailers and distributors were instructed to quarantine and discontinue the distribution of remaining stock.

If you are a retailer or healthcare provider with affected inventory:

Immediately quarantine all affected kits
Complete and return the required recall response documentation as instructed by SD Biosensor/Roche
Communicate recall information to all consumers and downstream distributors

Advice from the FDA and Manufacturer

Do not use expired or recalled Pilot COVID-19 At-Home Test kits
If exposed to buffer solution, follow first aid instructions and contact a medical professional if necessary
Dispose of all test components responsibly in the trash; do not pour chemicals down the drain
For any concerns, contact Roche customer support at the provided hotline

Current Status: All Kits Have Expired

The manufacturer has confirmed that all Pilot COVID-19 At-Home Test kits have now expired and are no longer for sale. Use of an expired test can further increase the risk of inaccurate results and is not recommended. The FDA urges all consumers to check the expiration on any test kits they possess and dispose of any outdated or recalled products properly.

What Types of COVID-19 Tests Have Been Authorized or Recalled?

The FDA maintains an evolving list of COVID-19 tests that have received either Emergency Use Authorization (EUA) or have been subject to recall or removal. As more self-testing kits entered the US market, the FDA’s oversight included periodic review for product safety and effectiveness.

For a current list of authorized tests and further recall information, consumers may reference the FDA’s medical device recall database and the FDA’s central COVID-19 testing resource.

Frequently Asked Questions (FAQs)

Which Pilot COVID-19 At-Home Test kits were recalled?

The recall impacted specific lots of the Pilot COVID-19 At-Home Test distributed between September and November 2022. For a complete list of affected lot numbers, consumers should consult the recall notice or contact Roche Support.

Is it safe to use a Pilot COVID-19 test I bought before 2023?

No. All of these kits have now expired, and using expired or recalled tests is strongly discouraged due to the risk of inaccurate results and possible contamination hazards.

What should I do if I already used a recalled test?

If you used a recalled test and experience any symptoms of infection—such as redness, pain, swelling, or fever—contact your healthcare provider immediately and inform them about your exposure to the potentially contaminated kit.

Will I be reimbursed if I purchased a recalled test?

For information on possible reimbursement or replacement, contact customer support at 1-866-987-6243 and follow the instructions provided by the manufacturer or your retailer.

Can I use test liquids in any other way or pour them down the drain?

No. The manufacturer instructs users to never pour test liquids or buffer solution down the drain. Dispose of the full kit in your household trash to avoid any contamination or environmental impact.

Where can I get updates about medical device recalls?

Visit the FDA’s medical device recall database or the FDA’s news and updates pages for the latest on device recalls and safety notifications.

Key Takeaways for Consumers

The Pilot COVID-19 At-Home Test was recalled due to bacterial contamination in the buffer solution—posing risk of severe infection.
All recalled lots are now expired and should be disposed of following safety guidelines.
If you experience symptoms after potential exposure, seek medical advice.
Stay informed on authorized self-test kits by checking FDA resources regularly.

More Resources

Pilot COVID-19 At-Home Test Consumer Support: 1-866-987-6243 (option 1)
FDA Medical Device Recall Database
FDA At-Home OTC COVID-19 Diagnostic Tests Listing

References

Author

medha deb

Medha Deb is an editor with a master's degree in Applied Linguistics from the University of Hyderabad. She believes that her qualification has helped her develop a deep understanding of language and its application in various contexts.

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