CLIN CHEM ALBUMIN BCG REAGENT
Received Apr 14, 2010 · Event occurred Feb 23, 2010
Report 2018433-2010-00067 · MDR key 1658261
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Product problems
- Nonstandard Device
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED ABBOTT REGARDING QUALITY CONTROLS OUT OF RANGE HIGH WHEN AN UNKNOWN LOT OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENT WITHOUT THIMEROSAL PRESERVATIVE WAS IN USE. THE CUSTOMER COMPARED THEIR CONTROL TARGET VALUES WITH ANOTHER TWO HOSPITAL SITES WHICH MATCHED THE VALUES FOR THE NEW REAGENT. 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