Recall Z-0938-2026 ยท GFO Activated Partial Thromboplastin
Instrumentation Laboratory
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
| Date | Dec 17, 2025 (initiated Nov 18, 2025) |
| Status | Open, Classified |
| Reason | Recalled lots were manufactured with double the amount of preservative concentration. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification, dated 11/18/25, was sent to consignees. Consignees are to contact Client Services at 1-800-955-9525 to arrange conversion to replacement lot N0956748, and in the meantime continue use of affected lots with the QC lot reassignments provided and run QC per labeled instructions for use. Once the replacement lot is received, consignees are to complete the cross-over study per laboratory procedures and immediately destroy affected devices, documenting destruction on the provided Mandatory Urgent Medical Device Recall Tracking Form which should be return |
| Quantity | 4,506 units |
| Distribution | Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955638 | SYNTHAFAX APTT REAGENT Ortho Diagnostic Systems, Inc., Apr 23, 1996 |