Class 2 Device Recall Panther(R) System

• Date Initiated by Firm: September 15, 2017
• Create Date: October 18, 2017
• Recall Status: Terminated on July 30, 2020
• Recall Number: Z-0027-2018
• Recall Event ID: 78216
• 510(K)Number: K132251
• Product Classification: Instrumentation for clinical multiplex test systems - Product Code NSU
• Product: Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
• Code Information: Serial Number 20900001124
• FEI Number: 2024800
• Recalling Firm/ Manufacturer: Hologic, Inc; 10210 Genetic Center Dr; San Diego CA 92121-4362
• For Additional Information Contact: Kathy Chester; 858-410-8444
• Manufacturer Reason for Recall: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
• FDA Determined Cause: Employee error
• Action: The customer was notifed of the potential incorrect results via a phone call on September 15, 2017. A customer letter was sent on September 18, 2017. The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017  Aug 30, 2017.
• Quantity in Commerce: 1 unit
• Distribution: Indiana
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = NSU