Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Recalled lots were manufactured with double the amount of preservative concentration.

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

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 returned to WERFEN by fax at 781-861-4207 or by email to ra-usa.na@werfen.com. All laboratory staff are to be notified of this recall and a copy of the notice posted near IL Coagulation Systems. Consignees with any questions are to contact Client Services at 1-800-955-9525.

• FDA enforcement recordOfficial FDA database entry for Z-0938-2026
• FDA 510(k) clearance · K955638The device's official FDA premarket clearance record
• FDA device classification · GFOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7925The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Instrumentation LaboratorySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.