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U.S. Department of Health and Human Services

Class 2 Device Recall EliA GBM Wells

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  Class 2 Device Recall EliA GBM Wells see related information
Date Initiated by Firm May 24, 2023
Date Posted January 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-0783-2024
Recall Event ID 93403
510(K)Number K140225  K173792  
Product Classification Test system, antineutrophil cytoplasmic antibodies (anca) - Product Code MOB
Product EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Code Information UDI-DI: 07333066010670; All Lots.
Recalling Firm/
Manufacturer		 Phadia Ab
Rapsgatan Plant
Rapsgatan 7
Uppsala Sweden
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MOB and Original Applicant = Phadia AB
510(K)s with Product Code = MOB and Original Applicant = PHADIA US INC.
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