Clinical Innovations, LLC Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Brand
Clinical Innovations, LLC
Lot Codes / Batch Numbers
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
Products Sold
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
Clinical Innovations, LLC is recalling Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6 due to Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On August 17, 2020 through August 19, 2020, the firm sent an "URGENT SAFETY NOTICE" to customers via email informing them that the incorrect swabs (non-scored) were package with their in vitro diagnostic kits and that new instructions and training material will be provided. Customers are instructed to identify any affected products and to complete the response card that is attached to the Customer Notification Letter. Customers are also provided the option of returning the affected products to the Recalling Firm. A company representative will contact and arrange for the return of the product For any questions contact the Recalling Firm at +1-801-268-8200.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IL, IN, MO, OH, RI, UT, VA
Page updated: Jan 10, 2026