ANTI-HUMAN GLOBULIN ANTI-IGG
Received Aug 23, 2011 · Event occurred Jun 22, 2011
Report 9610824-2011-00115 · MDR key 2254838
Device
Generic name
Ahg Anti-igg
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
804175100
Lot number
7039091-04
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THEY MISSED TWO ANTIBODIES (ANTI-E AND ANTI-CW) WITH ANTI-IGG ART#: (B)(4), LOT# 7039091-04. CUSTOMER HAS SENT US NEITHER THE PT SAMPLE NOR THE ALLEGEDLY DEFECTIVE SAMPLE ANTI-IGG. THEREFORE, THE RETENTION SAMPLE OF ANTI-IGG WAS TESTED IN OUR QUALITY CONTROL LAB, USING DIFFERENT WEAK ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING OF OUR QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ANTI-IGG. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.
Additional Manufacturer Narrative
ADD'L EVENT DATE: (B)(6) 2011.