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U.S. Department of Health and Human Services

Class 3 Device Recall Clinical Chemistry Immunoglobulin M, List Number 1E0120

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 Class 3 Device Recall Clinical Chemistry Immunoglobulin M, List Number 1E0120see related information
Date Initiated by FirmNovember 10, 2005
Date PostedJanuary 11, 2006
Recall Status1 Terminated 3 on March 20, 2007
Recall NumberZ-0384-06
Recall Event ID 34281
510(K)NumberK983132 
Product Classification Igm, Antigen, Antiserum, Control - Product Code DFT
ProductClinical Chemistry Immunoglobulin M, List Number 1E01-20
Code Information Lot Number(s): 30067HW00, 27057HW00, & 23026HW00
FEI Number 2018433
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information ContactMark Littlefield
972-518-6062
Manufacturer Reason
for Recall		These specific protein assays are not meeting the 57-day on board stability claim
FDA Determined
Cause 2		Other
ActionA Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
Quantity in Commerce1275 (212 in US)
DistributionNationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DFT
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