Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Panther(R) System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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/
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 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
-
-