Home › CLINICAL INNOVATIONS, LLC › ROM Plus®, Fetal Membranes Rupture Test
ROM Plus®, Fetal Membranes Rupture Test
CLINICAL INNOVATIONS, LLC · Model ROM-5025 · UDI-DI 00814247020437
NQM
Prescription
1
510(k) clearances
41
Adverse events (12 deaths)
3
Recalls
5
Facilities
Description
ROM Plus® Complete Kit Fetal Membranes Rupture Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-13 | Clinical Innovations, LLC | 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 use |
| 2020-02-21 | Qiagen Sciences LLC | An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute. |
| 2018-05-18 | Qiagen Sciences, Inc. | Potential for control line not appearing on the test strip |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.