Recall Z-1454-2015 ยท OYP Anti-Jcv Antibody Detection Assay
Focus Diagnostics Inc
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
| Date | Apr 17, 2015 (initiated Mar 15, 2015) |
| Status | Terminated |
| Reason | Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results. |
| Root cause | Nonconforming Material/Component |
| Action | Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require add |
| Quantity | 300 units |
| Distribution | Internationally: Denmark only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120986 | STRATIFY JCV DXSELECT Focus Diagnostics, Inc., Aug 16, 2012 |