OtherLSE
ANTI-FYB (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TEST
Received May 15, 2003 · Event occurred Apr 17, 2003
Report 2250051-2003-00111 · MDR key 461455
Device
Generic name
Blood Grouping Reagent
Manufacturer
Ortho-clinical DiagnosticsModel number
NICatalog number
103076
Lot number
FYB53A
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT NEGATIVE REACTIONS WERE OBSERVED WITH THIS LOT OF ANTI-FYB AND SEVERAL FYB+ CELLS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.
Remedial action
- Other