ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)
Received Jan 17, 2011 · Event occurred Oct 10, 2010
Report 9610824-2011-00007 · MDR key 1983144
Device
Generic name
Anti-human Globulin, Anti-igg, -c3d, Poly.
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
804115100
Lot number
7913070-02
Product problems
- False Negative Result
Patient
Not reported
- Test Result
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT CAP PROFICIENCY TEST FOR THE DAT B S ON SAMPLE #6 FAILED TO REACT POSITIVELY WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC ART NO. 804115100, LOT 7913070-02. THE CUSTOMER HAS SENT US NEITHER THE SURVEY SAMPLE NOR THE COMPLAINED REAGENT. THEREFORE, THE RETENTION SAMPLE WAS TESTED WITH THE SURVEY SAMPLE DAT-06 OF THE QUALITY CONTROL LABORATORY WHICH HAS THE SAME SPECIFICITY AS THE CONTROL USED BY CUSTOMER. THE SURVEY SAMPLE OF QC REACTED CORRECTLY POSITIVE WITH THE AFFECTED LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, C3D, POLYSPECIFIC.