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U.S. Department of Health and Human Services

Class 3 Device Recall TDx/TDxFLx Cortisol Reagent Pack

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 Class 3 Device Recall TDx/TDxFLx Cortisol Reagent Packsee related information
Date Initiated by FirmFebruary 16, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 26, 2004
Recall NumberZ-0723-04
Recall Event ID 28342
510(K)NumberK852927 K854419 
Product Classification Fluorometric, Cortisol - Product Code JFT
ProductTDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Code Information list 9116-65, lots 04111M200, 10239M200, 10060M200, 10060M201 
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
Manufacturer Reason
for Recall		The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
FDA Determined
Cause 2		Other
ActionField Correction recall by Important Product Information letter dated 2/16/04, sent via e-mail to the Abbott international subsidiaries on the same date for notification of all of their accounts receiving the Cortisol reagents and X Systems Cortisol controls since March 2002. The accounts were informed of the incorrect values for the Cortisol controls, when using the urinary free cortisol extraction procedure, listed in the package inserts of the reagent kits as well as the controls. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to use the corrected values as provided in the letter.
Quantity in Commerce1,487 kits
DistributionThere was no domestic distribution. The product was distributed internationally through Abbott subsidiaries in Canada, United Kingdom, Japan, Singapore, Hong Kong, Korea, Australia, New Zealand, Honduras, Costa Rica, Panama, Dominican Republic, Germany and Pakistan.
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 = JFT
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