Recall Z-1743-2022 ยท GGN Plasma, Coagulation Control
Aniara Diagnostica LLC
BIOPHEN UFH Control Plasma
| Date | Jun 28, 2022 |
| Status | Terminated |
| Reason | Incorrect product labeling was included in the package. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 13 units (1 unit is 1 box) |
| Distribution | Distribution in US - IL and MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR Hyphen Biomed, Dec 23, 2005 |