MalfunctionLDM
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATION KIT
Received Oct 12, 2004 · Event occurred Sep 22, 2004
Report 9680658-2004-00262 · MDR key 579979
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
8228595
Lot number
190
Product problems
- False Negative Result
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED OBTAINING A FALSE NEGATIVE HBSAG CONFIRMATORY RESULT ON A PATIENT SAMPLE. A FALSE NEGATIVE HBSAG CONFIRMATORY RESULT MAY PRESENT A RISK TO PUBLIC HEALTH. NO RESULTS WERE REPORTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.