Z-1743-2022 Class III Terminated
FDA device recall Z-1743-2022 was initiated by Aniara Diagnostica LLC on June 28, 2022 and is designated Class III. Reason for recall: Incorrect product labeling was included in the package. The recall status is terminated (terminated April 18, 2024). Affected quantity: 13 units (1 unit is 1 box).
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- June 28, 2022
- Termination Date
- April 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units (1 unit is 1 box)
Product Description
BIOPHEN UFH Control Plasma
Reason for Recall
Incorrect product labeling was included in the package.
Distribution Pattern
Distribution in US - IL and MI
Code Information
UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035