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U.S. Department of Health and Human Services

Class 3 Device Recall AxSYM Folate Specimen Diluent

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  Class 3 Device Recall AxSYM Folate Specimen Diluent see related information
Date Initiated by Firm December 16, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 20, 2004
Recall Number Z-0365-04
Recall Event ID 27978
510(K)Number K972232  
Product Classification unknown device name - Product Code CGN--
Product AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information List 3C81-50, lots 91555M100, 05920M200
Recalling Firm/
Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
Manufacturer Reason
for Recall
The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
FDA Determined
Cause 2
Action Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.
Quantity in Commerce 375 kits
Distribution There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.

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 = CGN-- and Original Applicant = ABBOTT LABORATORIES