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.
FDA Recall Z-0595-2018 · Posted None
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Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeNSU
Date Initiated2018-01-20
Date Terminated2022-07-28
Product Quantity103 units
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.
Firm Action
The firm sent an Urgent Medical Device Recall Notification dated January 8, 2018 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that a Hologic representative will contact your site to arrange a visit in order to provide an interim solution to secure the glass panel until a replacement monitor with the issue corrected can be installed. For questions contact Hologic Technical Support. at +1-888-484-4747 or +1-858-410-8511 or by e-mail at [email protected]
Root Cause
Device Design
Distribution Pattern
Worldwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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