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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott Diagnostics CELLDYN Diluent/Sheath Reagent

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  Class 3 Device Recall Abbott Diagnostics CELLDYN Diluent/Sheath Reagent see related information
Date Initiated by Firm December 22, 2006
Date Posting Updated March 01, 2007
Recall Status1 Terminated 3 on November 28, 2007
Recall Number Z-0565-2007
Recall Event ID 37234
510(K)Number K961439  K051215  K061667  
Product Classification in vitro diagnostic - Product Code GIF
Product CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
Code Information Lot Number 42063I2, List Number 01H73-01
Recalling Firm/
Manufacturer
Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
Manufacturer Reason
for Recall
Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
FDA Determined
Cause 2
Other
Action Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
Quantity in Commerce 652 (20 L. each) cubitainers
Distribution Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
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 = GIF and Original Applicant = ABBOTT DIAGNOSTICS
510(K)s with Product Code = GIF and Original Applicant = ABBOTT LABORATORIES
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