Clinical Innovations ROM Plus Collection Kit IFU: ROM recall
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Why was Clinical Innovations ROM Plus Collection Kit IFU: ROM recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
- Product
- Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
- Recalling firm
- Clinical Innovations, LLC
- Quantity
- 19450 units/kits
- Distribution
- US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
- Recall date
- December 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)