MalfunctionGHM
SICKLEDEX TUBE TEST OF HEMOGLOBIN S
Received Oct 3, 2003 · Event occurred Sep 4, 2003
Report 2250051-2003-01134 · MDR key 490468
Device
Generic name
Na
Manufacturer
Ortho-clinical Diagnostics, Inc.Model number
NICatalog number
773200
Lot number
3070
Product problems
- Incorrect Or Inadequate Test Results
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PT SAMPLE THAT REACTED POSITIVE IN MAY IS NOW REACTING NEGATIVE. NO REPORTED DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.