Clinical Innovations, LLC: Medical Device Recall in 2020 - (Recall #: Z-0541-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 13, 2020

Date Posted: December 16, 2020

Recall Number: Z-0541-2021

Event ID: 86255

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.

Status: Terminated

Product Quantity: 19450 units/kits

Code Information:

Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated