Z-0541-2021 Class II Terminated
FDA device recall Z-0541-2021 was initiated by Clinical Innovations, LLC on August 13, 2020 and is designated Class II. 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… The recall status is terminated (terminated May 24, 2024). Affected quantity: 19450 units/kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- August 13, 2020
- Termination Date
- May 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19450 units/kits
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.
Distribution Pattern
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Code Information
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631