Home › Device types › JHR
Radioimmunoassay, Immunoglobulins (D, E)
FDA product code JHR · Class 2 · Immunology
8
Registered devices
23
Adverse events
2
Recalls
9
510(k) clearances
Devices with this code
IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems TIE Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys IgE II Immunoassay — Roche Diagnostics GmbHElecsys IgE II — Roche Diagnostics GmbHIMMULITE® 2000 Systems TIE Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® Systems TIE CONTROL Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys IgE CalSet — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems TIE Total IgE Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-12-20 | Siemens Healthcare Diagnostics | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. |
| 2013-12-20 | Siemens Healthcare Diagnostics | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. |
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