CLIN CHEM ALBUMIN BCG REAGENT
Received Apr 12, 2010 · Event occurred Feb 18, 2010
Report 2018433-2010-00064 · MDR key 1656698
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Product problems
- Output above Specifications
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED A SHIFT OUT OF RANGE HIGH FOR THE CLINICAL CHEMISTRY ALBUMIN BCG QUALITY CONTROLS (QC) AFTER CALIBRATION. THE CUSTOMER HAD BEEN RUNNING THE ALBUMIN ASSAY ALL MORNING WITHOUT ERROR, THEN, THE CALIBRATION EXPIRED. RECALIBRATION OF THE ASSAY PASSED, HOWEVER, THE QC WAS VERY HIGH OUT OF RANGE WITH NO CHANGE TO THE CALIBRATOR LOT OR REAGENT KITS. THE CUSTOMER VERIFIED THE CORRECT CALIBRATOR SET POINTS AND PERFORMED OTHER RECOMMENDED TROUBLESHOOTING. THE CUSTOMER STATED RECALIBRATION PASSED SPECIFICATIONS WHEN THE CORRECT CALIBRATOR LEVEL WAS USED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C8000 ANALYZER, LIST # 1G06-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Recall