Lower risk Medical device recall · FDA · Published July 20, 2020

BD MAX SARS-CoV-2 Reagents Recall: False Positives Risk Delayed Diagnosis

Becton Dickinson recalls BD MAX SARS-CoV-2 Reagents due to potential false positive results that could delay diagnosis and increase COVID-19 exposure risk. All units affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2754-2020Medical device Becton Dickinson ›

Lower-risk recall

BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling SARS-CoV-2 reagents for the BD MAX System because they may cause false positive test results. This could delay diagnosis and lead to patients being exposed to COVID-19 if isolated with infected individuals. Read more at govinfonow.com/recall/64689-bd-max-sars-cov-2-reagents-recall-false-positives-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64689-bd-max-sars-cov-2-reagents-recall-false-positives-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2754-2020

Cite this page

“BD MAX SARS-CoV-2 Reagents Recall: False Positives Risk Delayed Diagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64689-bd-max-sars-cov-2-reagents-recall-false-positives-risk. Based on FDA recall #Z-2754-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2754-2020%22&limit=1).

The FDA announced on July 20, 2020, that Becton Dickinson & Co. is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results. The agency said the recall affects all lots distributed worldwide.

How to tell if you have it

Brand: Becton Dickinson
Product: BD MAX SARS-CoV-2 Reagents
Catalog No.: 445003 (UDI 00382904450038)
Catalog No.: 445003-01 (UDI (01)603829044500301)
Scope: All lots
Quantity: 30,392 units

The hazard

According to the FDA, false positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include BD GasP: CO2 Pouch System Recall (April 7, 2026), BD Kiestra Isolate Suspension Cuvette Array Recall (Oct. 23, 2025), and a product catalog security incident (Sept. 23, 2025). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025).

How to tell if you have this one

Check for product labels with the catalog number 445003 or 445003-01. All lots of these reagents are affected, so no specific purchase date is needed.

Brand
Becton Dickinson
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the catalog number 445003 or 445003-01 on the reagent packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 20 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Hawaii, Illinois, Indiana, Kentucky, Maryland, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Jul 20, 2020Firm started the recall
Aug 4, 2020FDA classified it Class II
Aug 12, 2020Published in FDA’s Enforcement Report
Jul 13, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these reagents?

No, the recall does not require stopping use. The reagents are affected but no specific remedy is stated.

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Link to this recall

<a href="https://govinfonow.com/recall/64689-bd-max-sars-cov-2-reagents-recall-false-positives-risk">BD MAX SARS-CoV-2 Reagents Recall: False Positives Risk Delayed Diagnosis (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2754-2020 (July 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2754-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.