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Instrumentation Laboratory: HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Medical DevicesSource: FDA (device) · Date: 2025-12-24

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Instrumentation Laboratory
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason / hazard
Recalled lots were manufactured with double the amount of preservative concentration.
Classification
Class III
Status
Ongoing
Distribution / 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.
Recall initiated
2025-11-18
Code info
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Product quantity
4,506 units
Voluntary mandated
Voluntary: Firm initiated
City
Bedford
State
MA
Country
United States
Event id
98019
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