EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
This recall is currently active, issued January 24, 2024. It was issued by Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden.
- Recall Initiated
- May 24, 2023
- Posted
- January 24, 2024
- Recall Number
- Z-0783-2024
- Quantity
- 124,928 kits
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide.
Lot / Code Info
UDI-DI: 07333066010670; All Lots.
Root Cause
Nonconforming Material/Component
Action Taken
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 results. 2) Until a resolution has been implemented and confirmed by Phadia AB, the use of the EliA GBM Well may be continued as detailed in the user manual and the DfU with the following recommendations: . For EliA GBM positive test results (>10 EliA U/ml): . Confirm positive EliA GBM results (>10 EliA U/ml) using an alternative method. If you do not have access to an alternative GBM method, please consider sending testing to your preferred reference laboratory for confirmation of positive results. . EliA GBM results d10 U/mL are not impacted by this issue and therefore these values can be reported according to the Interpretation of Test Results section on the EliA GBM DfU Customer Acknowledgement Must be returned prior to release of your next order of EliA GBM Wells If you have any questions concerning this issue, please contact Phadia US Technical Support at 1-800-346-4364, option #2.