Recall Z-0783-2024 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Phadia Ab
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
| Date | Jan 24, 2024 (initiated May 24, 2023) |
| Status | Open, Classified |
| Reason | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers on 5/24/23. 1) Review instrument logfiles or LIS for EliA GBM results that fall in the range >10 EliA U/ml according to your internal procedures. Log files may only be available for analysis for a limited timeframe of the Phadia Laboratory System due to storage and maintenance restrictions and may not cover the entire timeframe of the Instrument message log. . Should you need help, contact Phadia US Technical Support who can further assist in collecting log files and aid in identifying the potentially impacted test |
| Quantity | 124,928 kits |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |