Class 2 Device Recall Panther Fusion Extraction ReagentS

• Date Initiated by Firm: October 10, 2019
• Create Date: May 28, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2163-2020
• Recall Event ID: 85346
• 510(K)Number: K171963
• Product Classification: Respiratory virus panel nucleic acid assay system - Product Code OCC
• Product: 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
• Code Information: Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473
• Recalling Firm/ Manufacturer: Hologic, Inc; 10210 Genetic Center Dr; San Diego CA 92121-4362
• For Additional Information Contact: Suzanne Clancy; 858-410-8000
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 customers' site on Customer Response Form. Requested customers complete CRF per the accompanying instructions after segregation of affected product. 4) Requested customers return the completed CRF to Hologic Technical Support, even if they do not have any of the listed kits remaining in their inventory. 5) If customers identified any of the specified kits remaining in inventory (whether unopened or partial kits containing used reagent), requested they contact their technical support using the contact information provided for a replacement. One replacement kit was shipped proactively to minimize downtime due to this issue. 6) After completing the CRF, customers were instructed to destroy the segregated inventory and fax the documentation to the Hologic Technical Support using the fax number +1 858 410 8250 or scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com. If customers had any questions or concerns regarding the recall notification, they were to contact Hologic Technical Support at +1 888 484 4747 or +1 858 410 8511 during the hours of 5 am PDT and 5 pm PDT, or by email molecularsupport@hologic.com
• Quantity in Commerce: 47 kits
• Distribution: US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OCC and Original Applicant = Hologic, Inc.