Z-2171-2018 Class II Terminated
FDA device recall Z-2171-2018 was initiated by BioMerieux SA on Mar 23, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 23, 2020). Affected quantity: 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- Mar 23, 2018
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2171-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026