Class 2 Device Recall Abbott CellDYN

• Date Initiated by Firm: September 18, 2006
• Date Posted: December 05, 2006
• Recall Status: Terminated on November 28, 2007
• Recall Number: Z-0246-2007
• Recall Event ID: 36567
• 510(K)Number: K902892
• Product Classification: in vitro diagnostic - Product Code KRY
• Product: Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01
• Code Information: Lot Numbers: 3098, 3099, 3100
• Recalling Firm/ Manufacturer: Abbott Laboratories; 5440 Patrick Henry Dr; Santa Clara CA 95054-1113
• For Additional Information Contact: Michelle Roeding; 408-567-3781
• Manufacturer Reason for Recall: Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
• FDA Determined Cause: Other
• Action: The firm notified its consignees via customer letter sent on 09/18/2006, with information regarding the recall, requesting reply via a form included in the letter.
• Quantity in Commerce: 4708 units
• Distribution: Worldwide, including USA, Costa Rica, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, El Salvador, Germany, Japan, Philippines, Singapore, Hong Kong/China, Taiwan, Thailand, Malaysia, South Korea, Australia, New Zealand, Honduras, Nicaragua, Haiti, Bermuda, Virgin Islands, Panama, St. Eustatius, and St. Martin.
• 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 = KRY