Z-2171-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- March 23, 2018
- Termination Date
- June 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each
Product Description
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 Pattern
International distribution.
Code Information
Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508