FDAAugust 13, 2020device
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
clinical innovationsclinical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCArctic Zone Titan Pro Coolers Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Imported by California Innovations and Sold at Costco2026-06-11
- CPSCMerkury Innovations Recalls Hot + Cool Heating and Cooling Fans Due to Risk of Serious Injury or Death from Fire Hazard2026-06-11
- FDARoast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhesive label. The label reads in part as "***Lunch Box Kitchen*** Premium Convenience***Turkey & Cheddar Sub***BEST BY 06/14/26 Lot no. 26 134 NET WEIGHT: 6.1oz***KEEP REFRIGERATED*** Produced by: Produce Inno...2026-05-27
- FDAArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E2026-04-23
- FDAArvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C2026-04-23
- FDABrand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide ass...2026-03-09
- FDAHIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM...2025-12-17
- CPSCRomorgniz Fabric 12- and 13-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by Romorgniz2025-11-20
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