FDA recall Z-0938-2026

Instrumentation Laboratory · Class III · device

Product

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

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.

Key facts

Status
Ongoing
Initiation date
2025-11-18
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2026