HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA Recall #Z-0938-2026 — Class III — November 18, 2025
Product Description
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason for Recall
Recalled lots were manufactured with double the amount of preservative concentration.
Recalling Firm
Instrumentation Laboratory — Bedford, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated