FDA-Device2020-12-16Class II
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Clinical Innovations, LLC
Hazard
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
Sold states
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Affected count
19450 units/kits
Manufactured in
747 W 4170 S, N/A, Murray, UT, United States
Products
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0541-2021Don't want to check this manually?
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