CLIN CHEM ALBUMIN BCG REAGENT
Received Mar 30, 2010 · Event occurred Feb 7, 2010
Report 2018433-2010-00022 · MDR key 1645573
Device
Generic name
Quantitation Of Albumin In Human Serum Or Plasma
Manufacturer
Abbott Manufacturing, Inc.Catalog number
7D53-21
Lot number
77056HW00
Product problems
- Imprecision
- Nonstandard Device
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). ARCHITECT C16000 ANALYZER, LIST # 3L77-01, (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.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C16000 ANALYZER, LIST # 3L77-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISION FOR THE CLINICAL CHEMISTRY ALBUMIN BCG ASSAY WITH REAGENT LOT 77056HW00. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Remedial action
- Recall