SERACLONE ANTI-K (KEL1)
Received Aug 23, 2011 · Event occurred Jul 22, 2011
Report 9610824-2011-00113 · MDR key 2254818
Device
Generic name
Seraclone Anti-k
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
808 090 100
Lot number
7007130-01
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF SERACLONE ANTI-K WITH A KELL HETEROZYGOUS CELL FROM REAGENT RED BLOOD CELLS OF A COMPETITOR. THE CUSTOMER HAD SENT US THE ALLEGEDLY DEFECTIVE SAMPLE AND THE AFFECTED COMPETITOR'S REAGENT RED BLOOD CELLS. BOTH WERE RESTED AND REACTED CORRECTLY POSITIVE. THE ALLEGEDLY DEFECTIVE SAMPLE WAS TESTED WITH FURTHER K+K+ RED CELLS OF DONORS AND COMMERCIALLY AVAILABLE PANEL CELLS. ALL POSITIVE REACTIONS WERE CORRECT AND UNAMBIGUOUS POSITIVE. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED LOT OF SERACLONE ANTI-K. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED PRODUCT.
Additional Manufacturer Narrative
STN# 125230.