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ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy
Model 14-4990-01 · Phadia AB · DI 07333066005768
DHB — System, Test, Radioallergosorbent (Rast) Immunological · Class II · 21 CFR 866.5750
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2014-11-20 | Z-0947-2015 | Class II | Terminated | During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-07 | 0 | 1 |
| 2021-02 | 0 | 7 |
| 2023-03 | 0 | 1 |
| 2024-06 | 0 | 2 |
| 2024-11 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2026-03 | 0 | 3 |
Regulatory clearances
- K122197 SESE 2013-08-28 (k number procode)
Manufacturer compliance record — Phadia AB
- NAI 2013-11-21 Phadia GmbH · 0 citations
- NAI 2011-08-18 Phadia Ab · 0 citations
- NAI 2011-08-18 Phadia Ab · 0 citations