Z-0595-2018Class II

Hologic Panther(R) Fusion(TM), Catalog number ASY-09600

Name: Z-0595-2018 Hologic Panther(R) Fusion(TM), Catalog number ASY-09600
Creator: Hologic, Inc
Published: 2018-01-20
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2018-01-20 / Terminated / root cause: design

FDA source

Hologic, Inc began a recall of Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the... on 2018-01-20. FDA classified it as Class II and gives the reason as "The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0595-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-20
Posted: 2018-02-12
Terminated: 2022-07-28
Recalling firm: Hologic, Inc.
Product: 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.
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
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.
Root cause tag: design
FDA root cause: Device Design
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]
Quantity in commerce: 103 units
Distribution: Worldwide distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-12

Product code NSU

K132251Class IIAptima Combo 2 Assay (Panther System)Hologic / Gen-Probe Incorporated / cleared 2013-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)