# FDA recall Z-2754-2020

> **Becton Dickinson & Co.** · Class II · device recall initiated 2020-07-20.

## Product

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.

## 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.

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

## Key facts

- **Recall number:** Z-2754-2020
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-20
- **Report date:** 2020-08-12
- **Termination date:** 2021-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2754-2020

## Citation

> AI Analytics. FDA recall Z-2754-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2754-2020. Source: US FDA. Licensed CC0.

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