# FDA recall Z-2171-2018

> **BioMerieux SA** · Class II · device recall initiated 2018-03-23.

## Product

Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method.     Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

## Reason for recall

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

## Distribution

International distribution.

## Key facts

- **Recall number:** Z-2171-2018
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-23
- **Report date:** 2018-06-20
- **Termination date:** 2020-06-23

- **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-2171-2018

## Citation

> AI Analytics. FDA recall Z-2171-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2171-2018. Source: US FDA. Licensed CC0.

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