MalfunctionGMS
BIOCLONE ANTI-HUMAN GLOBULIN
Received May 17, 2007
Report 2250051-2007-70240 · MDR key 872771
Device
Generic name
Anti-human Globulin
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
716980
Lot number
RMG448C1
Product problems
- False Positive Result
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THAT A PROFICIENCY CROSSMATCH WAS REPORTED AS COMPATIBLE BUT THE RESULTS SHOULD HAVE BEEN INCOMPATIBLE. TESTING WAS PERFORMED WITH BIOCLONE ANTI-HUMAN GLOBULIN LOT RMG448C1. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.