Recall Z-1958-2014 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Focus Diagnostics Inc
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) fro
| Date | Jul 1, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage. |
| Root cause | Device Design |
| Action | Focus Diagnostics sent an Urgent Safety Notice Correction letter dated May 15, 2014, to all affected customers. The notification, informed customers of the product, the problem, and the action to be taken by the customer. To decrease the likelihood of obtaining any false results caused by either manually entering a spectral matrix or storing the DAD improperly after each use, please follow the recommended warnings and precautions provided in the revised and attached Simplexa Flu A/B & RSV Direct (PI.MOL2650 Rev. D) package insert. 1. The spectral matrix must be installed in each 3M Integrate |
| Quantity | 614 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK Focus Diagnostics, Inc., Jul 13, 2012 |