FDA Medical Device Recalls (openFDA)
Hologic, Inc: Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- Recall number
- Z-2990-2020
- Recalling firm
- Hologic, Inc
- Product
- Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
- Status
- Terminated
- Initiated
- 2020-08-04
- Posted
- not on file
- Terminated
- 2024-12-23
- 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.
- Root cause
- Under Investigation by 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.
- Quantity
- 607
- Distribution
- 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
- Lot, serial or model codes
- Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSU
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28