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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 22, 2003
Date Posted January 16, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall Number Z-0355-04
Recall Event ID 28041
Product Classification Photometric Method, Magnesium - Product Code JGJ
Product Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Code Information This is not a lot specific issue.
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
Manufacturer Reason
for Recall		 Complaints that instructions for use were not clear.
FDA Determined
Cause 2		 Other
Action Firm sent customer letters dated 12/22/2003 which included updated instructions for use.
Quantity in Commerce 215
Distribution Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador.
Total Product Life Cycle TPLC Device Report
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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