Class 3 Device Recall Abbott Diagnostics CELLDYN Diluent/Sheath Reagent

• Date Initiated by Firm: December 22, 2006
• Date Posted: March 01, 2007
• Recall Status: Terminated on November 28, 2007
• Recall Number: Z-0565-2007
• Recall Event ID: 37234
• 510(K)Number: K051215 K061667 K961439
• 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: 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; 510(K)s with Product Code = GIF