MalfunctionGHM
SICKLEDEX TUBE TEST HEMOGLOBIN S
Received Jul 23, 2003 · Event occurred Oct 19, 2001
Report 2250051-2003-00917 · MDR key 473995
Device
Generic name
Na
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NICatalog number
773500
Lot number
1045
Product problems
- False Negative Result
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT WITH A HISTORY OF SICKLE CELL TRAIT TESTED NEGATIVE WITH THIS PRODUCT. NO REPORTED DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.