Recall Z-2163-2020 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Hologic, Inc
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
| Date | Oct 10, 2019 |
| Status | Open, Classified |
| Reason | Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment. |
| Root cause | Nonconforming Material/Component |
| Action | Customers who received product/affected lot were to be contacted via Urgent: Medical Device Recall Notification Letter, dated October 10, 2019 via FedEx overnight. In addition to notifying customers about the recall, the recall notification asked customers to take the following actions: 1) Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-S kits and respective components listed in Table 1. 2) Immediately check inventory and segregate the Panther Fusion Extraction Reagent-S kit lot listed in Table 1. 3) Notified customers of the numbers of kits shipped to cust |
| Quantity | 47 kits |
| Distribution | US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusi Hologic, Inc., Sep 26, 2017 |