Recall Z-1095-2026 ยท GFO Activated Partial Thromboplastin
Instrumentation Laboratory
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
| Date | Jan 15, 2026 (initiated Dec 11, 2025) |
| Status | Open, Classified |
| Reason | Potential for microbial contamination. |
| Root cause | Under Investigation by firm |
| Action | Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided. |
| Quantity | 7,720 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060688 | HEMOSIL SYNTHASIL Instrumentation Laboratory CO, Apr 13, 2006 |