# FDA recall Z-0541-2021

> **Clinical Innovations, LLC** · Class II · device recall initiated 2020-08-13.

## 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

- **Recall number:** Z-0541-2021
- **Recalling firm:** Clinical Innovations, LLC
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0541-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0541-2021. Source: US FDA. Licensed CC0.

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