Class III

Medical Device Recall: HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory · November 18, 2025

Reason for Recall

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

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.

States Affected

AR, CA, CO, DE, FL, IL, IN, NY

Quantity Affected

4,506 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0938-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.