Date Initiated by Firm | September 30, 2003 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on April 07, 2004 |
Recall Number | Z-0091-04 |
Recall Event ID |
27495 |
510(K)Number | K980367 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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Product | AEROSET System Software version 1.02ER000 |
Code Information |
Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 152020 Irving TX 75015-2020
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Manufacturer Reason for Recall | Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. |
FDA Determined Cause 2 | Other |
Action | The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software. |
Quantity in Commerce | 133 |
Distribution | Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China |
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 = JQP
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