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U.S. Department of Health and Human Services

Class 2 Device Recall XSYSTEMS Dilution Buffer

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  Class 2 Device Recall XSYSTEMS Dilution Buffer see related information
Date Initiated by Firm September 01, 2004
Date Posted September 18, 2004
Recall Status1 Terminated 3 on November 30, 2004
Recall Number Z-1474-04
Recall Event ID 29957
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information list number 9519-02, all lots
Recalling Firm/
Abbott Laboratories HPD/ADD/GPRD
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Service
Manufacturer Reason
for Recall
The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.
FDA Determined
Cause 2
Action Abbott sent Device Correction letters dated 9/1/04 to all customers receiving the TDx/TDxFLx Benzodiazepines assay, list 9674, informing them of the shift in control values and patient results when used with the XSYSTEMS Dilution Buffer, list 9519-02. The letter gave examples of the effects observed in the benzodiazepines assay performance, and listed the following actions to be taken until Abbott completes their investigation: * During the use of a single lot of buffer, recalibrate the TDx/TDxFLx Benzodiazepines assay every 14 days. * Perform a new calibration run on the TDx/TDxFLx Benzodiazepines assay when a new lot number of XSYSTEMS Dilution Buffer is used. * These actions are in addition to the package insert calibration and quality control requirements. * Follow your laboratory procedures for notification of the health care providers that you serve. Any questions were directed to Abbott''s Customer Service at 1-877-4ABBOTT.
Quantity in Commerce 22,442 cartons
Distribution Nationwide and internationally to Argentina, Australia, Brazil, Chile, Colombia, Costa Rica, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Mexico, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, the United Kingdom, Uruguay and Venezuela
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.