Lower risk Medical device recall · FDA · Published January 7, 2021

Becton Dickinson BioGX SARS-CoV-2 Reagents Recall: Mislabeling Risk False Negatives

Becton Dickinson recalls BioGX SARS-CoV-2 Reagents for BD MAX System (catalog 444213) due to mislabeled N1/N2 pouches. This could cause false negatives in SARS-CoV-2 tests, risking missed diagnoses and spread of COVID-19.

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

🇺🇸 FDA recall #Z-0954-2021Medical device Becton Dickinson ›

Lower-risk recall

Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System (catalog 444213) because some pouches may be mislabeled, leading to false negative test results. This could mean a patient isn't properly diagnosed and might spread COVID-19 without knowing. Read more at govinfonow.com/recall/63462-becton-dickinson-biogx-sars-cov-2-reagents-recall-mislabeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63462-becton-dickinson-biogx-sars-cov-2-reagents-recall-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0954-2021

Cite this page

“Becton Dickinson BioGX SARS-CoV-2 Reagents Recall: Mislabeling Risk False Negatives.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63462-becton-dickinson-biogx-sars-cov-2-reagents-recall-mislabeling-risk. Based on FDA recall #Z-0954-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2021%22&limit=1).

The FDA announced on Jan. 7, 2021, that Becton Dickinson & Co. is recalling BioGX SARS-CoV-2 Reagents for BD MAX System catalog number 444213 due to potential mislabeled master mix pouches. This error could lead to false negative SARS-CoV-2 test results.

How to tell if you have it

Brand: Becton Dickinson
Product: BioGX SARS-CoV-2 Reagents for BD MAX System
Catalog number (REF): 444213
UPC: 00382904442132
Lot numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021

The hazard

Some N1 and N2 master mix pouches may be mislabeled, resulting in kits containing two pouches of the same type instead of one of each. If laboratory personnel use two identical pouches, there is a low potential for a false negative SARS-CoV-2 result, which could lead to increased disease progression risk and additional spread of the virus.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Recent brand recalls include a BD GasP CO2 Pouch System recall on 2026-04-07 and a BD Kiestra Isolate Suspension Cuvette Array recall on 2025-10-23. Other recent recalls of similar products include a Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24) and a BioFire Respiratory Panel 2.1 Recall (2025-10-22).

How to tell if you have this one

Check for catalog number 444213 and lot numbers K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, or K21-021 on the reagent packaging. The reagents are used in labs for SARS-CoV-2 testing via BD MAX System.

Brand
Becton Dickinson
Product
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Labels
Look for catalog number 444213 and lot numbers K20-507 through K21-021 on the reagent packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Jan 7, 2021Firm started the recall
Feb 5, 2021FDA classified it Class II
Feb 17, 2021Published in FDA’s Enforcement Report
Dec 3, 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 immediately. Laboratory personnel should check labels to ensure they are using the correct mix of pouches.

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Link to this recall

<a href="https://govinfonow.com/recall/63462-becton-dickinson-biogx-sars-cov-2-reagents-recall-mislabeling-risk">Becton Dickinson BioGX SARS-CoV-2 Reagents Recall: Mislabeling Risk False Negatives (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-0954-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0954-2021 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.