Recall Z-0783-2024— Phadia Ab
Class II · Ongoing
Class II FDA medical device recall by Phadia Ab, initiated 2023-05-24. It names 2 FDA 510(k) clearances: K173792, K140225. Product: EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic. 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..
- Recalling firm
- Phadia Ab
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-24
- Firm location
- Uppsala, N/A, Sweden
510(k) clearances named in this recall
2 on FDA's record- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.