REAGENT RED BLOOD CELLS BIOTESTCELL 3
Received Aug 3, 2011 · Event occurred Jul 6, 2011
Report 9610824-2011-00097 · MDR key 2209595
Device
Generic name
Biotestcell 3
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
816085100
Lot number
8123011
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF A D POSITIVE CONTROL SAMPLE WITH CELL 1 OF BIOTESTCELL 3. CUSTOMER HAD SENT NEITHER THE COMPLAINED LOT OF BIOTESTCELL 3 NOR THE CONTROL.
Additional Manufacturer Narrative
SUMMARY: THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. DUE TO THE CONFIRMED COMPLAINT A RISK ANALYSIS WAS PERFORMED. ON THE BASIS OF THE RESULT OF THE RISK ANALYSIS WE DECIDED THAT NO MARKET RELATED ACTIVITIES ARE NECESSARY. A CAPA HAS BEEN INITIATED TO INTENSIFY THE EFFORTS TO FIND THE ROOT CAUSE FOR THE COMPLAINT.