FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES
Received Sep 30, 2008 · Event occurred Sep 10, 2008
Report 1209263 · MDR key 1209263
Device
Generic name
Reagent, Monoclonal
Manufacturer
The Binding Site Inc.Model number
*Catalog number
*
Lot number
LOT# 257764A
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
UPON RECEIPT OF A NEW LOT OF REAGENT (THE BINDING SITE LTD., SAN DIEGO, CA, LOT #257764A)FOR SERUM FREE LIGHT CHAIN LAMBDA, OUR METHOD VALIDATION NOTED A SHIFT BETWEEN LOTS >40%. FREE LAMBDA CHAIN RESULTS DISPLAYED CLINICALLY SIGNIFICANT DIFFERENCES IN 4 OUT OF 5 PATIENTS AS WELL AS KAPPA/LAMBDA RATIO CHANGES IN 3 OUT OF 5 PATIENTS. ====================== MANUFACTURER RESPONSE FOR SPECIFIC LOT # OF REAGENT, FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES======================IN AN ATTEMPT TO RESOLVE THE PROBLEM, THE DISCREPANT SAMPLES WERE ALSO ASSAYED BY THE MANUFACTURER WHO REPORTED THE SAME DISCREPANCIES, BUT OFFERED NO SOLUTION TO THE PROBLEM. WE SUGGESTED THAT THE MANUFACTURER INFORM OTHER REAGENT USERS OF THE PROBLEM. MANUFACTURER INDICATED THAT THE PROBLEM WAS UNIQUE TO OUR LAB.