# FDA recall Z-0313-2019

> **Becton Dickinson & Co.** · Class II · device recall initiated 2018-09-24.

## Product

BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX  System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

## Reason for recall

A trend for false positive Candida glabrata results has been confirmed.  The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.

## Distribution

Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY,  LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and Turkey.

## Key facts

- **Recall number:** Z-0313-2019
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-24
- **Report date:** 2018-11-07
- **Termination date:** 2020-04-10

- **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-0313-2019

## Citation

> AI Analytics. FDA recall Z-0313-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0313-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*