Z-0824-2023 Class II Ongoing
FDA device recall Z-0824-2023 was initiated by Biomerieux Inc on Nov 9, 2022 and is designated Class II. Reason for recall: As the temperature and time out of range was exceeded, product performances cannot be guaranteed The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 03573026377717, Batch Numbers: 1009172020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0824-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026