FDA-Device2025-12-24Class III
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory
Hazard
Recalled lots were manufactured with double the amount of preservative concentration.
Sold states
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.
Affected count
4,506 units
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2026Don't want to check this manually?
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