inforMED
MalfunctionKZS

MDR event

Received Nov 8, 2006

Report 1056600-2006-00483 · MDR key 965127

Device

Product problems

  • Device Issue

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE E ANTIGENS. SATISFACTORY RESULTS WERE OBSERVED.