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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott CellDYN

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  Class 2 Device Recall Abbott CellDYN see related information
Date Initiated by Firm September 18, 2006
Date Posted December 05, 2006
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = UNIPATH LTD.
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