Z-0811-2023 Class II Ongoing
FDA device recall Z-0811-2023 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
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
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 03573026128142, Batch Numbers: 1009477900
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0811-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026