OtherCEK
ADIVA CHEMISTRY TOTAL PROTEIN REAGENT KIT
Received Oct 10, 2008 · Event occurred Sep 12, 2008
Report 2432235-2008-00118 · MDR key 1196535
Device
Generic name
Total Protein Chemistry Method
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
NACatalog number
01803350
Lot number
100789
Product problems
- Interference
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING STUDIES, IT WAS OBSERVED THAT THE ADVIA CHEMISTRY TOTAL PROTEIN METHOD DID NOT MEET CLAIMS OF NO SIGNIFICANT INTERFERENCE AT 1500 MG/DL DEXTRAN. THERE HAVE BEEN NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO POSITIVE DISCORDANT RESULTS.
Additional Manufacturer Narrative
REMEDIAL ACTION: THE DEXTRAN INTERFERENCE SECTION IN THE IFU WILL BE REVISED TO REFLECT CURRENT DATA.
Remedial action
- Relabeling