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HemosIL Liquid Anti-Xa

INSTRUMENTATION LABORATORY COMPANY · Model 0020302602 · UDI-DI 00195226000016

QLU Prescription
3
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities

Description

HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0020302622) 5 x 3 mL

Recalls

DateFirmReason
2021-08-25Instrumentation LaboratoryLabeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.