# FDA recall Z-1545-2018

> **Becton Dickinson & Co.** · Class III · device recall initiated 2018-03-02.

## Product

BD MAX DNA MMK Lab Use, catalog no. 442828

## Reason for recall

The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

## Distribution

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

## Key facts

- **Recall number:** Z-1545-2018
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-02
- **Report date:** 2018-05-09
- **Termination date:** 2018-07-02

- **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-1545-2018

## Citation

> AI Analytics. FDA recall Z-1545-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1545-2018. Source: US FDA. Licensed CC0.

---

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