Recall Z-0541-2021 ยท NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
Clinical Innovations, LLC
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
| Date | Aug 13, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | 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 produc |
| Quantity | 19450 units/kits |
| Distribution | US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110605 | ROM PLUS Clinical Innovations, LLC, Nov 23, 2011 |