Recall Z-2041-2023 ยท MST Antibodies, Gliadin
Phadia US Inc
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
| Date | Jun 30, 2023 (initiated May 1, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 9 units |
| Distribution | US: CA, NJ, MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 Phadia US, Inc., Aug 13, 2010 |