HERPESELECT 1 AND 2 HSV IMMUNOBLOT
Received Dec 21, 2007 · Event occurred Nov 21, 2007
Report 2023365-2007-00001 · MDR key 2136393
Device
Generic name
Immunoblot
Manufacturer
Focus Diagnostics, Inc.Model number
IB0900GCatalog number
IB0900G
Lot number
072216
Product problems
- Improper Chemical Reaction
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
FOCUS DIAGNOSTICS REC'D A COMPLAINT THAT THE HSV COMMON ANTIGEN BAND OF THE HERPESELECT 1 AND 2 HSV IMMUMNOBLOT IGG (B)(4) APPEARED LIGHTER (LESS REACTIVE) THAN THE READING CONTROL BAN. REDUCED REACTIVITY OF THE COMMON ANTIGEN BAND MAY LEAD TO THE INACCURATE INTERPRETATION OF A SAMPLE AS NEGATIVE. IN THE SPECIFIC CASE OF THE COMPLAINT THE PT RESULT WAS REPORTED AS INDETERMINATE.
Additional Manufacturer Narrative
A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. EARLY INVESTIGATION INDICATES THAT THE ANTIGEN LOT MAY BE AT ISSUE.
Remedial action
- Other