Z-0817-2023 Class II Ongoing
FDA device recall Z-0817-2023 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.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
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 03573026376567, Batch Numbers: 1009209480
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0817-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026