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U.S. Department of Health and Human Services

Class 2 Device Recall TDx/TDxFLx and TDxFLx Phenobarbital II Reagents

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  Class 2 Device Recall TDx/TDxFLx and TDxFLx Phenobarbital II Reagents see related information
Date Initiated by Firm November 17, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 01, 2004
Recall Number Z-0279-04
Recall Event ID 27780
510(K)Number K900940  
Product Classification Radioimmunoassay, Vancomycin - Product Code LEH
Product Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Code Information Reagent List 9500-60, lots 03136Q100, 92723Q102, 92723Q101, 92723Q100; and Reagent List 9500-85, lots 02285Q100, 92724Q100 that contain insert item number 69-5162/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 package inserts contain incorrect values for the alternate unit (¿mol/L) Control Ranges
FDA Determined
Cause 2		 Other
Action Field Correction recall by undated letter sent on 11/17/03 to all customers receiving the affected lots of reagents. The accounts were informed of the incorrect values for the alternate unit (¿mol/L) Control Ranges 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 use the correct values listed in the table for the assays. The letters also listed the package insert item numbers for the updated inserts being used in current reagent production.
Quantity in Commerce 5,603 kits
Distribution Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
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 = LEH and Original Applicant = ABBOTT LABORATORIES
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