FDA Recall
Terminated
BIOPHEN UFH Control Plasma
Recall: Z-1743-2022
·
Initiated June 28, 2022
Recall
- Recall Number
- Z-1743-2022
- Event Number
- 90765
- Firm
- Aniara Diagnostica LLC
- FEI Number
- 3005017664
- Product Code
- GGN
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- June 28, 2022
- Terminated
- April 18, 2024
- Address
- 7768 Service Center Dr, West Chester, OH, 45069-2442
Description
BIOPHEN UFH Control Plasma
Reason
Incorrect product labeling was included in the package.
Action
A recall notification letter was issued on August 3, 2022 to impacted consignees. Consignees were informed that the product is packaged with the incorrect insert ("flyer"). The recalling firm instructs consignees to destroy the included incorrect insert and use the attached correct insert. An Awareness Acknowledgement Form should be completed and returned to the recalling firm acknowledging that the information was received and the incorrect inserts were destroyed.
Distribution
Distribution in US - IL and MI
Quantity
13 units (1 unit is 1 box)