FDA recall Z-2171-2018

BioMerieux SA · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2018