Z-0595-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- January 20, 2018
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103 units
Product Description
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.
Reason for Recall
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
Distribution Pattern
Worldwide distribution
Code Information
Serial Numbers: 2090002307, 2090002308, 2090002309, 2090002310, 2090002311, 2090002312, 2090002339, 2090002340, 2090002341, 2090002342, 2090002343, 2090002344, 2090002345, 2090002346, 2090002347, 2090002348, 2090002349, 2090002350, 2090002351, 2090002352, 2090002353, 2090002359, 2090002360, 2090002361, 2090002362, 2090002363, 2090002366, 2090002367, 2090002368, 2090002369, 2090002370, 2090002371, 2090002372, 2090002373, 2090002374, 2090002381, 2090002382, 2090002383, 2090002384, 2090002385, 2090002387, 2090002388, 2090002389, 2090002390, 2090002391, 2090002393, 2090002404, 2090002405, 2090002406, 2090002407, 2090002409, 2090002411, 2090002413, 2090002414, 2090002415, 2090002420, 2090002421, 2090002422, 2090002428, 2090002429, 2090002430, 2090002432, 2090002433, 2090002434, 2090002435, 2090002436, 2090002437, 2090002438, 2090002446, 2090002447, 2090002448, 2090002449, 2090002450, 2090002451, 2090002452, 2090002458, 2090002462, 2090002465, 2090002466, 2090002467, 2090002468, 2090002469, 2090002470, 2090002471, 2090002472, 2090002473, 2090002476, 2090002481, 2090002483, 2090002484, 2090002485, 2090002338, 2090002394, 2090002417, 2090002431, 2090002463, 2090002464, 2090002492, 2090002491, 2090002490, 2090002489, 2090002488