OtherJTL
ORTHO SUMMIT PROCESSOR
Received Apr 13, 2005 · Event occurred Mar 17, 2005
Report 2250051-2005-50118 · MDR key 592352
Device
Generic name
Elisa Microwell Plate Processor
Manufacturer
Hamilton Bonaduz AgModel number
7003015Catalog number
936480
Lot number
*
Product problems
- Low Readings
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ORTHO SUMMIT PROCESS INSTRUMENT REPORTEDLY PROCESSED 12 MICROWELL PLATES WITH ONE ROW OF MICROWELLS ON EACH PLATE CONSISTENTLY READING JOW ODS AND NEGATIVE ODS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.