MalfunctionMZP
HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT
Received Jun 8, 2010 · Event occurred May 24, 2010
Report MW5016285 · MDR key 1723076
Device
Product problems
- Cross Reactivity
- Device Slipped
- Device Contamination with Body Fluid
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
FROM (B) (6) 2010 TO (B) (6) 2010: CAPS ON THE WELLS OF THE LYSIS RACK DO NOT CLOSE TIGHTLY CAUSING CROSS-CONTAMINATION OF THE SPECIMEN AND ALSO CONTAMINATION OF CENTRIFUGE. DATES OF USE: #1 - (B) (6) 2010 - (B) (6) 2010; #2 - (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: #1 - (B) (6) VIRAL LOAD ASSAY; #2 (B) (6) VIRAL LOAD ASSAY.