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
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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
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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 |
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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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