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IMMULITE® Systems TIE CONTROL Total IgE
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10385349 · UDI-DI 00630414953458
1
510(k) clearances
23
Adverse events
2
Recalls
6
Facilities
Description
IgE total - IMMULITE - CTL - 2x2mL
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.