# FDA recall Z-0218-2019

> **BioMerieux SA** · Class II · device recall initiated 2018-09-17.

## Product

NucliSENS¿ Magnetic Extraction Reagents

## Reason for recall

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

## Distribution

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

## Key facts

- **Recall number:** Z-0218-2019
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-10-31
- **Termination date:** 2020-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0218-2019

## Citation

> AI Analytics. FDA recall Z-0218-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0218-2019. Source: US FDA. Licensed CC0.

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