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Elecsys IgE II Immunoassay
Roche Diagnostics GmbH · Model 4827031190 · UDI-DI 04015630922369
JHR
Prescription
1
510(k) clearances
23
Adverse events
2
Recalls
6
Facilities
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
