Abbott Laboratories Inc. ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases the following errors may be generated. -ARCHITECT cSystems: Error Code 1053 (Unable to calculate result, rate reaction linearity failure) -AEROSET: RL% Error Code Revised P

Recommended Action

Per FDA guidance

Abbott Laboratories sent a Product Correction letter dated August 5, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Update your assay parameters for A-AST 1. Follow the steps in the appropriate attachment: - Use Attachment A for ARCHITECT cSystems - Use Attachment B for AEROSET. 2. All A-AST results of less than (<) 5 U/L should be evaluated by comparing to other clinically relevant assays Retain a copy of this letter for your laboratory records. For questions regarding this recall call 626-440-0705.