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Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled December 24, 2025 · FDA recall Z-0938-2026 · Instrumentation Laboratory
Hazard
Recalled lots were manufactured with double the amount of preservative concentration. · FDA Class III
Units
4,506 units
Sold at
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.
Description
Recalled lots were manufactured with double the amount of preservative concentration.
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Manufacturer(s)
Instrumentation Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →