CAPTURE-R SELECT
Received Sep 22, 2006 · Event occurred Aug 24, 2006
Report 1034569-2006-00119 · MDR key 870635
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED IN A DONOR SAMPLE THAT CONTAINED A PURPORTED ANTI-VEL ANTIBODY USING CAPTURE R SELECT.
Additional Manufacturer Narrative
TESTED CUSTOMER'S SAMPLE IN HEMAGGLUTINATION TESTING USING PANOSCREEN I, II, III, LOT 28317 USING IMMUADD AS THE POTENTIATOR. REACTIVITY WAS ONLY OBSERVED AT IAT WITH ALL THREE REAGENT RED CELLS. THE CUSTOMER'S SAMPLE WAS TESTED WITH CRRS(4), LOT G140 IN MANUAL SOLID PHASE TEST AND RETENTION CAPTURE R SELECT LOT SC050. THE SAMPLE REACTED WITH LIQUID RED CELLS WHEN USING CAPTURE SELECT, BUT DID NOT REACT WITH 3 OF THE 4 CELLS WHEN USING THE READY SCREEN FORMAT.