FDA recall Z-0541-2021

Product

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

Reason for recall

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.

Distribution

US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None

Key facts

Status

Terminated

Initiation date

2020-08-13

Report date

2020-12-16

Termination date

2024-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0541-2021