Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Immunology · 21 CFR 866.5510
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Kamiya Biomedical Company, LLCOpen, ClassifiedNov 21, 2022
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Z-0271-2023 · View FDA record ↗ - Beckman Coulter IncTerminatedJul 23, 2004
IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit.
Inconsistent and incomplete results for IgG.
Z-1149-04 · View FDA record ↗ - Helena Laboratories, Corp.TerminatedUnknown
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
The plates do not have wells punched for the controls in the patient 1 area.
Z-0045-2020 · View FDA record ↗ - Helena Laboratories, Corp.Open, ClassifiedUnknown
V8 Immunodisplacement Kit REF 1803
Due to microbial growth causing interference with interpretation.
Z-1244-2022 · View FDA record ↗
Registered firms
36 firms currently registered for this product code
510(k) clearances
29 clearances for this product code
- SebiaNov 12, 2021
K203184 · HYDRASHIFT 2/4 isatuximab
- SebiaNov 1, 2019
K192095 · CAPI 3 Immunotyping, Capillarys 3 Tera
- SebiaMay 2, 2019
K190851 · HYDRASHIFT 2/4 daratumumab
- SebiaJan 11, 2018
K172195 · HYDRASHIFT 2/4 daratumumab, daratumumab Control
- SebiaDec 21, 2016
K161928 · CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- SebiaJan 8, 2015
K143483 · MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
- Grifols USA, LLCAug 24, 2012
K120169 · INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
- Helena Laboratories Uk, Ltd.Jun 26, 2012
K111369 · THE HELENA V8 IMMUNODISPLACEMENT KIT