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U.S. Department of Health and Human Services

Class 2 Device Recall Panther(R) System

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  Class 2 Device Recall Panther(R) System see related information
Date Initiated by Firm September 15, 2017
Create Date October 18, 2017
Recall Status1 Terminated 3 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
Recalling Firm/
Hologic, Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Kathy Chester
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 2
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 and Original Applicant = HOLOGIC / GEN-PROBE INCORPORATED