MalfunctionDAF
ANTI-HUMAN GLOBULIN BIOCLONE
Received Nov 13, 2008 · Event occurred Oct 13, 2008
Report 2250051-2008-70501 · MDR key 1269083
Device
Generic name
Anti-human Globulin Reagents
Manufacturer
Ortho-clinical DiagnosticsModel number
*Catalog number
716980
Lot number
RMG451B1
Product problems
- False Negative Result
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTING FALSE NEGATIVE RESULTS WHEN PERFORMING VALIDATION TESTING OF ORTHO ANTI-HUMAN GLOBULIN BIOCLONE, RMG451B1, AND AN IMMUCOR REAGENT. A SAMPLE WITH ANTI-E DID NOT REACT WITH RMG451B1. WEAK - 1+ REACTIVITY WAS OBSERVED WITH THE IMMUCOR REAGENT. SATISFACTORY QC TESTING WAS OBSERVED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.