5 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS C 311 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 26, 2024
ELECSYS CHAGAS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code QHM·August 9, 2024
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
FDA Enforcement
Class II
·Ongoing·Wiener Laboratories·March 14, 2018
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
FDA Recall
Open, Classified
·Wiener Laboratories Street Riobamba Argentina·Product code MIU·November 10, 2017
WIENER LABORATORIOS S.A.I.C.
FDA registration
WIENER LABORATORIOS S.A.I.C.·50 products·🇦🇷 Argentina