| Class 3 Device Recall TDx/TDxFLx Salicylate | |
Date Initiated by Firm | December 05, 2003 |
Date Posted | February 04, 2004 |
Recall Status1 |
Terminated 3 on April 25, 2005 |
Recall Number | Z-0509-04 |
Recall Event ID |
27971 |
510(K)Number | K844070 |
Product Classification |
unknown device name - Product Code DKJ--
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Product | TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 |
Code Information |
All lots with insert versions 69-6373/R4, 69-6003/R3 or 66-6296/R2. The corrected insert is version 34-3033/R5. |
Recalling Firm/ Manufacturer |
Abbott Laboratories HPD/ADD/GPRD 100/200 Abbott Park Road Abbott Park IL 60064
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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. % Recovery incorrect. |
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 | 1,999 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. |
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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.
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510(K) Database | 510(K)s with Product Code = DKJ--
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