| Class 2 Device Recall CELLDYN Ruby |  |
Date Initiated by Firm | April 16, 2010 |
Date Posted | September 02, 2010 |
Recall Status1 |
Terminated 3 on December 06, 2010 |
Recall Number | Z-2352-2010 |
Recall Event ID |
56309 |
510(K)Number | K061667 |
Product Classification |
Differential Cell Counter - Product Code GKZ
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Product | CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. |
Code Information |
Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- 08H67-01/35286BG-35318BG, 34891BG, 34641BG, 34408BG, 34890BG, 34021BG |
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 | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support. |
Quantity in Commerce | 69 units total |
Distribution | Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay. |
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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