Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of… — Class II medical device recall Z-0541-2021
Terminated recall by Clinical Innovations, LLC, reported 2020-12-16, distributed in CO, IL, IN, MO, OH, RI, UT, VA. Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were ass
| Recall number | Z-0541-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Innovations, LLC, Murray, UT, United States |
| Recall initiated | 2020-08-13 |
| Classified | 2020-12-07 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2024-05-24 |
| Distributed | CO, IL, IN, MO, OH, RI, UT, VA |
| Quantity | 19,450 units |
| Reason classes | device malfunction |
| Lot numbers | 192353, 192359, 192438, 192631 |
| Model numbers | ROM-5025, ROM-6025 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0541-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.