Drug recall
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
FDA recall event 86255 · Class II · Clinical Innovations, LLC
Key facts
| Event ID | 86255 |
|---|---|
| Recall numbers | Z-0541-2021 |
| Recalling firm | Clinical Innovations, LLC |
| Product type | Devices |
| Products | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 13, 2020 |
| Report date | Dec 16, 2020 |
| Termination date | May 24, 2024 |
| City | Murray |
| State | UT |
| Country | United States |
| FEI number | 1000220650 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: