Class II — Clinical Innovations, LLC
| Recalling firm | Clinical Innovations, LLC |
|---|---|
| Registered facility | CLINICAL INNOVATIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 |
| Quantity | 19450 units/kits |
| Distribution | US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None |
| Initiated | 2020-08-13 |
| Classified | 2020-12-07 |
| Terminated | 2024-05-24 |
| Recall number | Z-0541-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Clinical Innovations, LLC (Z-0541-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86255/
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