FDA-Device2021-10-27Class II
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
Instrumentation Laboratory
Hazard
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Sold states
US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom Gibraltar Greece Hong Kong Hungary Indonesia Ireland Israel India Iran Italy¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ Japan South Korea Kuwait Kazakhstan Lebanon Sri Lanka Lithuania Luxembourg Macau Mexico Malaysia Netherlands Poland Portugal Qatar Reunion Romania Serbia Russia Saudi Arabia Sweden Thailand Tunisia Turkey Taiwan Vietnam Zambia
Affected count
25,738 US
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2022Don't want to check this manually?
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