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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 28, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 on September 16, 2004
Recall Number Z-0803-03
Recall Event ID 25990
510(K)Number K981580  
Product Aeroset Direct HDL Reagent, LN 7D67-01
Code Information Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission Street
South Pasadena CA 91030
For Additional Information Contact Mark Littlefield
Manufacturer Reason
for Recall
Degredation prior to expiry date.
FDA Determined
Cause 2
Action Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.
Quantity in Commerce 1409
Distribution Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.

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.
510(K) Database 510(K)s with Product Code = and Original Applicant = ABBOTT LABORATORIES