| Class 2 Device Recall AEROSET |  |
Date Initiated by Firm | October 02, 2001 |
Date Posted | May 20, 2003 |
Recall Status1 |
Terminated 3 on April 07, 2004 |
Recall Number | Z-0843-03 |
Recall Event ID |
25770 |
510(K)Number | K980367 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product | Aeroset Analyzer, item 9D05-01 |
Code Information |
All units on the market prior to 12/3/2001. |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 2020 Irving TX 75038
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Manufacturer Reason for Recall | Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule. |
FDA Determined Cause 2 | Other |
Action | The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system. |
Quantity in Commerce | 238 units |
Distribution | Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England |
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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