Recall archive / FDA device enforcement
BIOPHEN UFH Control Plasma — FDA record Z-1743-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BIOPHEN UFH Control Plasma
- Reason
- Incorrect product labeling was included in the package.
- Classification
- Class III
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 13 units (1 unit is 1 box)
- Agency-reported status
- Terminated
- Source record identifier
- Z-1743-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution in US - IL and MI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Jun 28, 2022
- Center classification date
- Sep 15, 2022
- Termination date
- Apr 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.