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Recall Observatory FDA recall evidence

Device product

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Z-2990-2020

August 04, 2020

Class II

Product summary

Firm
Hologic, Inc
Event
Event 86248
Status
Terminated
Classification
Class II
Quantity
607
Official record key
device-enforcement:Z-2990-2020

Official wording

Reason: 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.

Code information: Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.