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Hologic, Inc recalls Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Recalled September 30, 2020 · FDA recall Z-2990-2020 · Hologic
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. · FDA Class II
Units
607
Sold at
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
Description
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.
Product
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →