MalfunctionCEK
QUANTTTEST RED
Received Oct 3, 2002
Report MW1026346 · MDR key 420464
Device
Generic name
Laboratory Test Kit
Manufacturer
QuantimetrixModel number
*Catalog number
5210-12
Lot number
*
Product problems
- Design/structure problem
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE QUANTTEST RED TOTAL PROTEIN ASSAY SYSTEM KIT MARKETED BY QUANTIMETRIX AND BEING USED TO MEASURE URINE PROTEINS DOES NOT MEASURE LIGHT CHAINS AND THEREFORE GIVES AN INACCURATE MEASURE OF URINARY PROTEIN IN PTS WITH LIGHT CHAIN PROTEINURIA. THE MFR ACKNOWLEDGES THIS PROBLEM, BUT THERE IS NO INDICATION IN THE PRODUCT LITERATURE OF THIS PROBLEM.