Recall Z-0541-2021— Clinical Innovations, LLC
Class II · Terminated
Class II FDA medical device recall by Clinical Innovations, LLC, initiated 2020-08-13, terminated 2024-05-24. It names one FDA 510(k) clearance: K110605. Product: Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025. Reason: 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..
- Recalling firm
- Clinical Innovations, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-13
- Terminated
- 2024-05-24
- Firm location
- Murray, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.