BIOPHEN UFH Control Plasma
This recall has been terminated (originally issued June 28, 2022).
- Company
- Aniara Diagnostica Llc
- Recall Initiated
- June 28, 2022
- Terminated
- April 18, 2024
- Recall Number
- Z-1743-2022
- Quantity
- 13 units (1 unit is 1 box)
- Firm Location
- West Chester, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect product labeling was included in the package.
Distribution
Distribution in US - IL and MI
Lot / Code Info
UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
Root Cause
Under Investigation by firm
Action Taken
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.