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Terminated

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

FDA Recall Z-2990-2020 · Posted None

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeNSU
Date Initiated2020-08-04
Date Terminated2024-12-23
Product Quantity607

Reason for Recall

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.

Firm Action

On 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.

Root Cause

Under Investigation by firm

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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