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Clinical Innovations, LLC recalls Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Recalled December 16, 2020 · FDA recall Z-0541-2021 · Clinical Innovations
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. · FDA Class II
Units
19450 units/kits
Sold at
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Description
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.
Product
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Manufacturer(s)
Clinical Innovations, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →