TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall Z-0509-04 · Posted 2004-02-04
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Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeDKJ
Date Initiated2003-12-05
Date Terminated2005-04-25
Product Quantity1,999 kits
Reason for Recall
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. % Recovery incorrect.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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