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.
Z-2171-2018
Product summary
- Firm
- BioMerieux SA
- Event
- Event 80111
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each
- Official record key
device-enforcement:Z-2171-2018
Official wording
Reason: 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.
Code information: Color Gram 2 (COLOR GRAM 2 - F) (ref: 55542) Lot number G64508
Distribution pattern: International distribution.
Derived failure modes
-
Unknown
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.