FDA-Device2020-09-30Class II
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Hologic, Inc
Hazard
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
Sold states
U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
Affected count
607
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2990-2020Don't want to check this manually?
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