MalfunctionCEP
ARCHITECT LH
Received Aug 10, 2007 · Event occurred Sep 21, 2006
Report 1415939-2007-00208 · MDR key 891709
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing Hormone
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-22
Lot number
33198M200
Product problems
- Unknown (for use when the device problem is not known)
Patient
NI YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED, THAT THE LH CONTROL VALUES, RUN ON THE ARCHITECT ANALYZER, IS OUT OF RANGE HIGH. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall