FDA Medical Device Recalls (openFDA)
Phadia Ab: EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
- Recall number
- Z-0783-2024
- Recalling firm
- Phadia Ab
- Product
- EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
- Status
- Open, Classified
- Initiated
- 2023-05-24
- Posted
- 2024-01-24
- Terminated
- not on file
- 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 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.
- Quantity
- 124,928 kits
- Distribution
- US Nationwide.
- Lot, serial or model codes
- UDI-DI: 07333066010670; All Lots.
- 510(k) numbers
- ["K140225","K173792"]
- PMA numbers
- not on file
- Product code
- MOB
- Firm FEI
- 3002807876
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28