Clinical Innovations Recalls ROM Plus Collection Kits Due to Swab Defect
Clinical Innovations is recalling ROM Plus Collection Kits because incorrect swabs may cause false test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where incorrect results can occur, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Clinical Innovations, LLC is recalling approximately 19,450 units of the ROM Plus Collection Kit (ROM Plus Rupture of Membrane Test, models ROM-5025 and ROM-6025). The recall is due to the inclusion of incorrect, non-scored sample collection swabs in the in vitro diagnostic kits.
The defective swabs may lead to false negative or false positive test results if the user does not break the swab stick correctly or if scissors or other tools are used to cut the swab handle. The affected lots are ROM-5025 (Lot 192438) and ROM-6025 (Lots 192353, 192359, and 192631).
The products were distributed in Colorado, Illinois, Indiana, Missouri, Ohio, Rhode Island, Utah, and Virginia. Users should stop using the affected kits and contact Clinical Innovations, LLC for further instructions.
The recalled product
- Product
- Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
- Manufacturer
- Clinical Innovations, LLC
- Affected units
- 19,450
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 192359
- 192631
Distribution
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