Recall Z-1189-2019 ยท GGN Plasma, Coagulation Control
Aniara Diagnostica LLC
BIOPHEN UFH Control C1, REF 224101
| Date | Mar 19, 2019 |
| Status | Terminated |
| Reason | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. |
| Root cause | Error in labeling |
| Action | On March 18, 2019, the recalling firm notified its two affected customers of the recall via email. The email included an attached Urgent Medical Device Correction letter from HYPHEN BioMed, which informed customers that incorrect instructions for use had been packaged into specific lots of three device product codes. Customers were instructed to destroy the incorrect IFUs and begin using the corrected IFUs. Customers were also asked to complete and return customer response forms to Aniara Diagnostica. |
| Quantity | 41 units |
| Distribution | Distributed to accounts in MI and PA. |
| 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 |