JHRClass II

Radioimmunoassay, Immunoglobulins (d, E)

Immunology · 21 CFR 866.5510

MDR events23All time

Recalls2All time

Registered firms14Currently listed

510(k) clearances9All time

Recent MDR events

23 adverse event reports on file

Event type breakdown

Malfunction23

Most-reported manufacturers

Roche Diagnostics23

Recalls

2 recall events for this product code

Siemens Healthcare Diagnostics
TerminatedApr 25, 2014
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with th
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Z-1517-2014 · View FDA record ↗
Siemens Healthcare Diagnostics
TerminatedApr 25, 2014
IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd.
Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Z-1518-2014 · View FDA record ↗

Registered firms

14 firms currently registered for this product code

510(k) clearances

9 clearances for this product code