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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMarch 28, 2003
Date PostedMay 09, 2003
Recall Status1 Terminated 3 on September 16, 2004
Recall NumberZ-0803-03
Recall Event ID 25990
510(K)NumberK981580 
ProductAeroset Direct HDL Reagent, LN 7D67-01
Code Information Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission Street
South Pasadena CA 91030
For Additional Information ContactMark Littlefield
972-518-6062
Manufacturer Reason
for Recall		Degredation prior to expiry date.
FDA Determined
Cause 2		Other
ActionFirm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.
Quantity in Commerce1409
DistributionNationwide 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) Database510(K)s with Product Code =
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