Class 2 Device Recall Abbott

• Date Initiated by Firm: October 16, 2002
• Date Posted: March 13, 2003
• Recall Status: Terminated on August 21, 2003
• Recall Number: Z-0648-03
• Recall Event ID: 25028
• 510(K)Number: K010953 K981342 K971152 K961439
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System CELL-DYN REAGENT; ; Model/List Number 01H73-01
• Code Information: Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)
• Recalling Firm/ Manufacturer: Abbott Laboratories; 5440 Patrick Henry Drive; Santa Clara CA 95054
• For Additional Information Contact: Amy Sams; 408-567-3457
• Manufacturer Reason for Recall: Product elicits fluorescent signal interference due to contamination.
• FDA Determined Cause: Other
• Action: On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
• Quantity in Commerce: 1383 units
• Distribution: Nationwide and Argentina, Canada and Puerto Rico.
• 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 = GKZ and Original Applicant = ABBOTT DIAGNOSTICS; 510(K)s with Product Code = GKZ and Original Applicant = ABBOTT LABORATORIES