# FDA recall Z-2047-2020

> **Becton Dickinson & Co.** · Class II · device recall initiated 2020-04-14.

## Product

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

## Reason for recall

May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.

## Key facts

- **Recall number:** Z-2047-2020
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-14
- **Report date:** 2020-05-27
- **Termination date:** 2022-02-10

- **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-2047-2020

## Citation

> AI Analytics. FDA recall Z-2047-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2047-2020. Source: US FDA. Licensed CC0.

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