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U.S. Department of Health and Human Services

Class 3 Device Recall IMx Folate Ion Capture Component Set

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  Class 3 Device Recall IMx Folate Ion Capture Component Set 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-0372-04
Recall Event ID 27978
510(K)Number K943691  
Product Classification unknown device name - Product Code CGN--
Product IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information List 2220-88, lots 90376M300 and 90376M301
Recalling Firm/
Manufacturer		 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		 Other
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 196 sets
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 MFG., INC.
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