MalfunctionMZP
COBAS TAQSCREEN MPX TEST, VERSION 2.0
Received May 3, 2017 · Event occurred Mar 31, 2017
Report 6547933 · MDR key 6547933
Device
Generic name
Cobas Taqscreen Mpx Test, Version 2.0
Manufacturer
Roche Molecular Systems, Inc.Lot number
X06559
Product problems
- False Positive Result
- False Positive Result
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
FALSE POSITIVE RATES USING THE ROCHE MOLECULAR SYSTEMS, INC COBAS TAQSCREEN MPX TEST, VERSION 2.0 EXCEEDED WHAT IS PUBLISHED IN THE PACKAGE INSERT.