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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Emerald Hematology Analyzer

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  Class 2 Device Recall CELLDYN Emerald Hematology Analyzer see related information
Date Initiated by Firm July 16, 2009
Date Posted October 19, 2009
Recall Status1 Terminated 3 on December 06, 2010
Recall Number Z-0065-2010
Recall Event ID 52964
510(K)Number K081495  
Product Classification Counter, differential cell - Product Code GKZ
Product CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA.

Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Code Information All Serial Numbers under Product Listing Number: 09H39-01.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact
408-982-4800
Manufacturer Reason
for Recall		 Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.
FDA Determined
Cause 2		 Software design
Action Abbott Diagnostics issued a "Product Correction" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions. For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should contact your local hematology customer support representative.
Quantity in Commerce 411 units
Distribution Worldwide Distribution -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.
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 LABORATORIES
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