![]() 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. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. Possible false negative or false positive results. ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Product Code NQMĬlinical Innovations ROM Plus Collection Kit Immunoassay for detection of amniotic fluid protein(s). Class 2 Device Recall ROM Plus Rupture of Membrane Test ![]()
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