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U.S. Department of Health and Human Services

Class 3 Device Recall TDx/TDxFLx CReactive Protein Reagents

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  Class 3 Device Recall TDx/TDxFLx CReactive Protein Reagents see related information
Date Initiated by Firm December 05, 2003
Date Posted February 04, 2004
Recall Status1 Terminated 3 on April 25, 2005
Recall Number Z-0507-04
Recall Event ID 27971
510(K)Number K854542  
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
Product TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Code Information All lots with insert version 66-9771/R3. The corrected insert is version 34-2897/R4.
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
FDA Determined
Cause 2		 Other
Action Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory.
Quantity in Commerce 1,644 kits
Distribution Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DCK and Original Applicant = ABBOTT LABORATORIES
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