EliA GBM Wells, Material Number 14551401, for Phadia 250… recallZ-0783-2024 · Phadia Ab · initiated May 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Phadia Ab or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0783-2024
- Status
- Open, Classified
- Initiated by the company
- May 24, 2023
- Posted by the FDA
- Jan 24, 2024
- Recalling firm
- Phadia Ab
- Quantity
- 124,928 kits
- Product code
- MOB
- FDA submissions
- K140225, K173792
- Distribution
- US Nationwide.
Product description
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Code information (models, lots, serial numbers)
UDI-DI: 07333066010670; All Lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EliA GBM Well DECC055140Phadia AB · Devices, measure, antibodies to glomerular basement membrane (gbm)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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