Z-0783-2024Class II

EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

Name: Z-0783-2024 EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Creator: Phadia Ab
Published: 2023-05-24
License: https://open.fda.gov/license/

Phadia AB / initiated 2023-05-24 / Open, Classified / root cause: manufacturing process

FDA source

Phadia Ab began a recall of EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic on 2023-05-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0783-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-24
Posted: 2024-01-24
Recalling firm: Phadia AB
Product: EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Product code: MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 124,928 kits
Distribution: US Nationwide.
Product codes and lots: UDI-DI: 07333066010670; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0783-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0783-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-24

Product code MOB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)