HemosIL SynthAFax. Partial Thromboplastin Time Tests. (Instrumentation Laboratory) – recalled lots were manufactured with ... (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AR, CA, CO, DE, FL, IL, IN, NY