Events

Recall of Device Recall ARCHITECT/AEROSET Activated Aspartate Aminotransferase

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50072
  • Event Risk Class
    Class 2
  • Event Number
    Z-1447-2012
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2012-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74631
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
  • Reason
    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
    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.

Device

Device Recall ARCHITECT/AEROSET Activated Aspartate Aminotransferase
  • Model / Serial
    List Numbers 8L91-20: 57028HW00, 59035HW00, 61031HW00, 64052HW00; List Numbers 8L91-40: 57017HW00, 59031HW00, 61038HW00, 64050HW00
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including Germany
  • Product Description
    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
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Manufacturer Address
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA