# FDA recall Z-0443-2019

> **bioMerieux, Inc.** · Class II · device recall initiated 2018-10-08.

## Product

bioM¿rieux NucliSENS  easyMAG Lysis Buffer ref. 280134

## Reason for recall

Some eluates  become colored because of remaining hemoglobin in the eluate.

## Distribution

CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and   WI  Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

## Key facts

- **Recall number:** Z-0443-2019
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-08
- **Report date:** 2018-11-21
- **Termination date:** 2021-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0443-2019

## Citation

> AI Analytics. FDA recall Z-0443-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0443-2019. Source: US FDA. Licensed CC0.

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