# FDA recall Z-0765-2021

> **Becton Dickinson & Co.** · Class II · device recall initiated 2020-12-08.

## Product

BD Phoenix" PMIC-109: IVD  is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli    Catalog Number: 448419

## Reason for recall

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0765-2021
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-08
- **Report date:** 2021-01-06
- **Termination date:** 2023-10-03

- **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-0765-2021

## Citation

> AI Analytics. FDA recall Z-0765-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0765-2021. Source: US FDA. Licensed CC0.

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