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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79007

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hologic, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0595-2018
Recall number
Z-0595-2018
Initiated
January 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Hologic, Inc
Quantity
103 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

Worldwide distribution