| Class 2 Device Recall CELLDYN Emerald Hematology Analyzer |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GKZ
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