BEUDAMED
    FDA Enforcement Class III Ongoing

    HemosIL SynthAFax. Partial Thromboplastin Time Tests.

    Recall: Z-0938-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0938-2026
    Event ID
    98019
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Instrumentation Laboratory
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 24, 2025
    Initiation Date
    November 18, 2025
    Classification Date
    December 17, 2025
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443, United States

    Description

    HemosIL SynthAFax. Partial Thromboplastin Time Tests.

    Reason

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

    Code Info

    Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).

    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.

    Quantity

    4,506 units