FDAHealthNovember 18, 2025
Instrumentation Laboratory — HemosIL SynthAFax. Partial Thromboplastin Time Tests.
⚠️ Recalled lots were manufactured with double the amount of preservative concentration.
Is this relevant to me?
- Geography
- CA, CO, FL, NY, AR, AT, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN
- Source agency
- FDA
- Category
- Health
- Published
- November 18, 2025
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.
What's affected?
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Lot code
- No
Additional details
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 4,506 units.
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