MalfunctionCEP
ARCHITECT LH
Received Jul 26, 2007 · Event occurred Feb 6, 2007
Report 1415939-2007-00202 · MDR key 885309
Device
Generic name
Cmia For The Quantitative Determination Of Human Luteinizing Hormone
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
6C25-27
Lot number
33198M201
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 WHILE RUNNING THE ARCHITECT I2000SR, ERROR CODE #1227 (ASSAY (LH)NUMBER(641) CALIBRATION FAILURE, FIT CONCENTRATION TOO HIGH FOR CAL F) GENERATED BEFORE AND AFTER CALIBRATION USING THE LH ASSAY REAGENT. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Remedial action
- Recall