6 results
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38ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Malfunction
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124 OSOM COMBO HCG 25T KIT
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS, LLC·Product code JHI·April 8, 2014
OSMO ULTRA HCG COMBO TEST URINE PREGNANCY TEST
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS LLC.·Product code JHI·August 21, 2024
OSOM ULTRA STREP A 25 TEST KIT
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS, LLC·Product code GTY·October 22, 2025
OSOM HCG COMBO TEST
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS, LLC·Product code JHI·January 20, 2023
OSOM CARD PREGNANCY TEST
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS, LLC·Product code JHI·September 20, 2016
HCG/QUAL
FDA Adverse Event
Malfunction
·SEKISUI DIAGNOSTICS, LLC·Product code JJX·January 8, 2026