MalfunctionKSS
CAPTURE-R SELECT
Received Aug 15, 2014 · Event occurred Jul 18, 2014
Report 1034569-2014-00151 · MDR key 4013410
Device
Generic name
Solid Phase System For The Immobilization Of Human Erythrocytes
Manufacturer
Immucor, Inc.Catalog number
0006446
Lot number
SC280
Product problems
- False Negative Result
Patient
43 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC ACCESS METHOD TO ASSESS THE INSTRUMENT ELECTRONIC IMAGES. SAMPLE IN QUESTION REACTED NEGATIVE WITH MULTIPLE LOTS OF CAPTURE REAGENTS AND DIFFERENT UNIT SAMPLES. COULD NOT RULE OUT SAMPLE RELATED ISSUE.
Description of Event or Problem
ON (B)(6) 2014 AN IMMUCOR FIELD PERSONNEL REPORTED FALSE NEGATIVES ON AN IGG CROSS-MATCH PERFORMED ON GALILEO ECHO INSTRUMENT WITH CAPTURE-R SELECT LOT SC280.