Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to Recalled by Becton Dickinson & Co. Due to Assays may produce false negative results due to...

Date: May 7, 2024
Company: Becton Dickinson & Co.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Co. directly.

Affected Products

BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.

Quantity: 2,061 kits

Why Was This Recalled?

Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Becton Dickinson & Co.

Becton Dickinson & Co. has 183 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report