Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
This recall has been terminated (originally issued August 13, 2020).
- Company
- Clinical Innovations, Llc
- Recall Initiated
- August 13, 2020
- Terminated
- May 24, 2024
- Recall Number
- Z-0541-2021
- Quantity
- 19450 units/kits
- Firm Location
- Murray, UT
- Official Source
- View on FDA website ↗
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
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Lot / Code Info
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
Root Cause
Process change control
Action Taken
On August 17, 2020 through August 19, 2020, the firm sent an "URGENT SAFETY NOTICE" to customers via email informing them that the incorrect swabs (non-scored) were package with their in vitro diagnostic kits and that new instructions and training material will be provided. Customers are instructed to identify any affected products and to complete the response card that is attached to the Customer Notification Letter. Customers are also provided the option of returning the affected products to the Recalling Firm. A company representative will contact and arrange for the return of the product For any questions contact the Recalling Firm at +1-801-268-8200.