Z-2990-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 4, 2020
- Termination Date
- December 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 607
Product Description
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
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.
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
Code Information
Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351