Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Recall date

November 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0938-2026

FDA classification

Class III

Brand / firm

Instrumentation Laboratory

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

HemosIL SynthAFax. Partial Thromboplastin Time Tests.