Recall Z-0846-2014 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Focus Diagnostics Inc
Simplexa Flu A/B & RSV Direct assay, Model MOL2650. 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) from human patients with signs and symptoms of respiratory
| Date | Jan 28, 2014 (initiated Jan 10, 2014) |
| Status | Terminated |
| Reason | Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate. |
| Root cause | Pending |
| Action | Focus Diagnostics sent an Urgent Safety Notice Correction letter dated January 10, 2014, via email and a hard copy letter by mail. The letter informed customers of the correction, product description with codes, product intended use, issue, risk to health, background, recommendation, actions by customers, and contact information. Customers were instructed to check their inventory for the affected product, if customers detect any positive RSV results, confirm the positive result by an alternate method. Customers were asked to complete the "URGENT: SAFETY NOTICE Acknowledgement and Receipt Form |
| Quantity | 1,052 kits |
| Distribution | Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. . |
| 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 |