VIDAS® LYME IGG
Received Oct 21, 2015
Report 3002769706-2015-00125 · MDR key 5163878
Device
Product problems
- False Positive Result
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
ON (B)(6) 2015, A FRENCH CUSTOMER CONTACTED BIOMERIEUX TO INFORM THEM THEY HAVE FAILED THE NATIONAL QUALITY CONTROL ORGANIZED BY BIOLOGIE PERSPECTIVE ON (B)(6) 2015 FOR THE TEST VIDAS LYME IGG REF. 30320 WITH THE LOT 1003560430. THE IGG RESULT FOR THIS SAMPLE WAS EXPECTED TO BE NEGATIVE.
Additional Manufacturer Narrative
BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THE INVESTIGATION TESTING INCLUDED TWO (2) DIFFERENT LOTS OF VIDAS® LYME IGG. RESULTS OF "NEGATIVE" WERE OBTAINED FOR BOTH LOTS WHEN TESTING THE BIOLOGIE PROSPECTIVE 2015 2A SPECIMEN. THE POSITIVE RESULT OBTAINED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE VIDAS® LYME IGG ASSAY IS PERFORMING IN ACCORDANCE WITH SPECIFICATIONS.