Reported Jun 20, 2018 · Terminated
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct…
BioMerieux SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Color Gram 2 (COLOR GRAM 2 - F) (ref55542) Lot number G64508
- Amount recalled
- 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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