Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
This recall is currently active, issued June 30, 2023. It was issued by Phadia Us Inc.
- Company
- Phadia Us Inc
- Recall Initiated
- May 1, 2023
- Posted
- June 30, 2023
- Recall Number
- Z-2041-2023
- Quantity
- 9 units
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Distribution
US: CA, NJ, MI
Lot / Code Info
UDI: 07333066020938 All Serial Numbers
Root Cause
Under Investigation by firm
Action Taken
Themofisher Scientific/Phadia US issued Urgent Medical Device Recall Letter-Medical Device Field Safety Notice issued May 1, 2023. Letter states reason for recall, health risk and action to take: d13 EliA U/mL (due to risk of false positive EliA GliadinDP IgG results in this range) according to your internal procedures. Log files may only be available for analysis for a limited timeframe on the Phadia Laboratory System due to storage and maintenance restrictions and may not cover the entire timeframe of the Instrument message log. " As noted above in section 1.3, also review test results for Total IgA and EliA Celikey IgA (if tested) to identify potential IgA deficient patients. " 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) Use of the EliA GliadinDP IgG Well on Phadia 2500EE can continue as detailed in the user manual and the DfU with the following recommendations: " For EliA GliadinDP IgG results that fall in the range of e10 to d13 EliA U/mL (due to risk of false positive EliA GliadinDP IgG results) and are IgA deficient: a. Verify positive EliA GliadinDP IgG results using a Phadia 250 instrument if available. Use the result generated on the Phadia 250 to report patient results in line with the user manual and DfU. b. As another option, you may wish to verify positive EliA GliadinDP IgG results by running EliA Celikey IgG on your existing, Phadia 2500EE. It is important to note that EliA Celikey IgG is not a direct alternative for EliA GliadinDP IgG and results generated are not readily interchangeable. Both EliA tests are designed to assist in the diagnosis of celiac disease. Further scientific background on this recommendation can be provided by Phadia s US Technical Support team. c. If you do not have direct access to a Phadia 250 instrument in your laboratory or utilize EliA Celikey IgG, please contact Phadia s US Technical Suppor