| Class 2 Device Recall AEROSET |  |
Date Initiated by Firm | February 24, 2003 |
Date Posted | April 16, 2003 |
Recall Status1 |
Terminated 3 on October 28, 2004 |
Recall Number | Z-0725-03 |
Recall Event ID |
25625 |
510(K)Number | K980367 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product | AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02 |
Code Information |
No codes: Catalog numbers 2-89996-01 and 2-89996-02 |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 2020 Irving TX 75038
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For Additional Information Contact | Mark Ellis 520-570-2000 |
Manufacturer Reason for Recall | Under certain operating conditions, smart wash feature disables with multiple samples. |
FDA Determined Cause 2 | Other |
Action | A device correction letter was sent 02/24/2003 to all AEROSET customers with a US Customer Reply Form. A Technical Service Bulletin will be released to include the Device Correction letter and instructions for Field Service Personnel. A Quality Directive will be issued to provide instructions to Customer Service. |
Quantity in Commerce | 645 units |
Distribution | Nationwide and to Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, and New Zeland |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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