CLIN CHEM ALBUMIN BCG REAGENT
Received Mar 30, 2010 · Event occurred Feb 19, 2010
Report 2018433-2010-00014 · MDR key 1645492
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Lot number
77056HW00
Product problems
- Nonstandard Device
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG CALIBRATOR AND BIORAD CONTROLS LEVELS FROM 12 TO 19% TOO HIGHER WHEN ALBUMIN REAGENT LOT 77056HW00 WAS IN USE. THE ABBOTT CUSTOMER SERVICE REPRESENTATIVE REQUESTED DATA FOR EVALUATION. THE ALBUMIN ASSAY WAS SCHEDULED TO BE REINSTALLED ON THE ANALYZER AND A NEW LOT OF CALIBRATOR WAS SENT TO THE CUSTOMER FACILITY. 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.
Additional Manufacturer Narrative
(B)(4). ARCHITECT C8000 ANALYZER, LIST # 1G06-01, (B)(4). THE CAUSE OF THE PARTICULATE MATTER (PENICILLIUM SP, A FUNGAL SPECIES FOUND IN THE ENVIRONMENT) OBSERVED IN SOME CLINICAL CHEMISTRY ALBUMIN BCG REAGENT CARTRIDGES WAS DUE TO EXPOSURE OF THE ALBUMIN BCG FORMULA CONTAINING WEAK ANTIMICROBIAL ADDITIVE FROM NORMAL FORMULATION AND FILTERING PROCESSES DESIGNED FOR MICROBIAL GROWTH CONTROLLED CLINICAL CHEMISTRY REAGENTS. ABBOTT ISSUED A PRODUCT RECALL ADVISING CUSTOMERS TO DISCARD OR DESTROY ANY INVENTORY OF THREE AFFECTED LOTS OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENTS. ABBOTT IS IDENTIFYING ALTERNATE FORMULATION FOR THE CLINICAL CHEMISTRY ALBUMIN REAGENTS THAT CONTAIN NO MERCURY.
Remedial action
- Recall