ELECSYS CMV IGG ASSAY

Additional Manufacturer Narrative

THE CUSTOMER'S CALIBRATION RECOVERY WAS FOUND TO BE ACCEPTABLE. THE CUSTOMER'S QC RECOVERY WAS FOUND TO BE ACCEPTABLE. THE PROVIDED SAMPLE WAS TESTED USING A RECOMLINE CMV IGG BLOT. THE BLOT TESTING FOUND THE SAMPLE TO SHOW NO CMV SPECIFIC REACTIVITY (NEGATIVE RESULT), WHICH CONFIRMS THE NEGATIVE RESULT THE CUSTOMER PREVIOUSLY RECEIVED ONSITE. THE INVESTIGATION FOUND THE CMV IGG ASSAY TO BE PERFORMING WITHIN SPECIFICATIONS.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS 6000 E 601 MODULE. THE RESULT FROM THE E601 MODULE WAS < 0.150 U/ML (NEGATIVE) WITH A DATA FLAG. THE SAMPLE WAS REPEATED BY THE ABBOTT, LIAISON AND VIDAS METHODS WITH THE FOLLOWING RESULTS: ABBOTT: 14.7 U/ML (POSITIVE), LIAISON: 24 U/ML (POSITIVE), VIDAS: 8 U/ML (POSITIVE). ON (B)(6) 2020 THE RESULT FROM THE E601 MODULE WAS < 0.150 U/ML (NEGATIVE). THIS SAMPLE WAS ALSO REPEATED BY THE ABBOTT, LIAISON AND VIDAS METHODS WITH THE FOLLOWING RESULTS: ABBOTT: 17 U/ML (POSITIVE), LIAISON: 26 U/ML (POSITIVE), VIDAS: 6 U/ML (POSITIVE). THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION AND TESTED WITH CMV IGG REAGENT 450074 ON AN E602 MODULE. THE CUSTOMER'S NEGATIVE CMV IGG RESULTS WERE REPRODUCED.