CAPTURE-R SELECT
Received Apr 8, 2014 · Event occurred Mar 11, 2014
Report 1034569-2014-00057 · MDR key 3734631
Device
Generic name
Solid Phase System For The Immobilization Of Human Erythrocytes
Manufacturer
Immucor, Inc.Catalog number
0006446
Lot number
SC262
Product problems
- Incorrect Or Inadequate Test Results
Patient
88 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IMMUCOR TECHNICAL SUPPORT USED REMOTE ELECTRONIC ACCESS METHOD TO ASSESS THE GALILEO NEO ELECTRONIC IMAGES ON (B)(4) 2014. THE WELL IMAGES FOR THE UNEXPECTED CROSSMATCH COMPATIBLE WELLS ALL APPEARED AS UNEXPECTED NEGATIVE WITH ASSOCIATED TIGHTLY DEFINED RED BLOOD CELL BUTTONS. IMMUCOR LABORATORY TESTED RETENTION PRODUCTS ON (B)(4) 2014 AND ALL RETENTION PRODUCTS PERFORMED AS EXPECTED. THE CUSTOMER RETURNED BLOOD SAMPLES TO IMMUCOR FOR TESTING, AND ON (B)(4) 2014 THE IMMUCOR LABORATORY DUPLICATED THE UNEXPECTED COMPATIBLE CROSSMATCH RESULTS. THE UNEXPECTED CROSSMATCH COMPATIBLE RESULTS HAVE A POTENTIAL FOR A TRANSFUSION ERROR.
Description of Event or Problem
ON (B)(6) 2014, A CUSTOMER REPORTED UNEXPECTED COMPATIBLE CROSSMATCH RESULTS WHEN USING CAPTURE-R SELECT ON A GALILEO NEO INSTRUMENT ON (B)(6) 2014.