Recall Z-2990-2020
Hologic, Inc · initiated August 4, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Codes / lots: Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2990-2020
- Initiated
- August 4, 2020
- Terminated
- December 23, 2024
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- 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
- Recalling firm
- Hologic, Inc, San Diego, CA