MalfunctionJHJ
CLINITEK STATUS ANALYZER
Received Jan 6, 2012 · Event occurred Dec 13, 2011
Report 1217157-2011-00054 · MDR key 2412595
Device
Generic name
Clinitek Status Analyzer
Manufacturer
Siemens Healthcare Diagnostics, Mfg., Ltd.Model number
CT STATUSProduct problems
- False Positive Result
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
CUSTOMER REPORTED A FALSE POSITIVE HCG ON LOT# 030998. PT HAD A SCHEDULED COLPOSCOPY CANCELLED. SERUM RESULT NEGATIVE. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
A PRODUCT RECALL WAS INSTITUTED BY THE MFR FOR THE CLINITEST HCG LOT# 030998 REPORTED IN THIS EVENT.