Becton Dickinson & Co.: Medical Device Recall in 2020 - (Recall #: Z-2754-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

Product Classification:

Class II

Date Initiated: July 20, 2020

Date Posted: August 12, 2020

Recall Number: Z-2754-2020

Event ID: 86061

Reason for 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.

Status: Terminated

Product Quantity: 30,392 to date

Code Information:

All lots are affected

Distribution Pattern:

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, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated