Z-1189-2019 Class III Terminated
FDA device recall Z-1189-2019 was initiated by Aniara Diagnostica LLC on March 19, 2019 and is designated Class III. Reason for recall: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. The recall status is terminated (terminated July 12, 2019). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 19, 2019
- Termination Date
- July 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
BIOPHEN UFH Control C1, REF 224101
Reason for Recall
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Distribution Pattern
Distributed to accounts in MI and PA.
Code Information
Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1