ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is

FDA device recall Z-1447-2012 · posted 2012-04-23 · Terminated

Recall details

Recalling firm

Abbott Laboratories Inc.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CIT

Quantity affected

1,646

Distribution

Worldwide Distribution including Germany

Date initiated

2008-06-30

Date posted

2012-04-23

Date terminated

2012-04-23

Location

South Pasadena, CA

Related 510(k) clearances