MalfunctionGMS
ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)
Received Jan 17, 2011 · Event occurred Oct 15, 2010
Report 9610824-2011-00005 · MDR key 1983143
Device
Generic name
Anti-human Globulin, Anti-igg, -c3d, Poly.
Manufacturer
Bio-rad Med Diagnostics GmbhCatalog number
804115100
Lot number
7836090-02
Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT CAP SURVEY (B)(4) FAILED TO REACT (B)(6) WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC (B)(4), LOT 7836090-02. THE CUSTOMER HAS SENT US THE SURVEY SAMPLE AND THE COMPLAINED REAGENT. BOTH WERE TESTED IN QUALITY CONTROL LABORATORY. THE SURVEY SAMPLE REACTED CORRECTLY (B)(6) WITH THE AFFECTED LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC.