Z-0863-2023 Class II Ongoing
FDA device recall Z-0863-2023 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: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
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 03573026254681, Batch Numbers: 1009261260, Research use only
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0863-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026