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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 November 03, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 29, 2004
Recall Number Z-0208-04
Recall Event ID 27684
Product Classification Fluorescence Polarization Immunoassay, Phenobarbital - Product Code LGQ
Product AEROSET Phenobarbital, LN 1E08-01
Code Information Lots: 01066HW00 expires 10/31/2003 06030HW00 expires 4/30/2004 08060HW00 expires 7/31/2004
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Mark Littlefield
972-518-6062
Manufacturer Reason
for Recall		 Assay is imprecise.
FDA Determined
Cause 2		 Other
Action Firm telephoned customers on 11/3/2003 and followed up with a letter offering credit or replacement.
Quantity in Commerce 112
Distribution Nationwide, Mexico, England and Canada
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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