Reported Dec 16, 2020 · Terminated
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Clinical Innovations, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clinical Innovations, LLC · 747 W 4170 S · Murray, UT · 84123-1364
Is this the product you have?
- Clinical
- Innovations ROM Plus Collection Kit IFU
ROM Plus Rupture of Membrane Test ROM-5025ROM-6025
- Lot codes and dates
- Model NumberROM-5025
- Lot Number192438
- Model NumberROM-6025
- Lot Numbers
192353192359192631
- Amount recalled
- 19450 units/kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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