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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT/AEROSET Activated Aspartate Aminotransferase

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  Class 2 Device Recall ARCHITECT/AEROSET Activated Aspartate Aminotransferase see related information
Date Initiated by Firm June 30, 2008
Date Posted April 23, 2012
Recall Status1 Terminated 3 on April 23, 2012
Recall Number Z-1447-2012
Recall Event ID 50072
510(K)Number K071525  
Product Classification Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
Product 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
Code Information List Numbers 8L91-20: 57028HW00, 59035HW00, 61031HW00, 64052HW00; List Numbers 8L91-40: 57017HW00, 59031HW00, 61038HW00, 64050HW00
Recalling Firm/
Manufacturer
Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact
626-440-0705
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 1,646
Distribution Worldwide Distribution including Germany
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CIT and Original Applicant = ABBOTT LABORATORIES
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