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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Sapphire

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 Class 2 Device Recall CELLDYN Sapphiresee related information
Date Initiated by FirmApril 16, 2010
Date PostedSeptember 02, 2010
Recall Status1 Terminated 3 on December 06, 2010
Recall NumberZ-2353-2010
Recall Event ID 56309
510(K)NumberK051215 
Product Classification Differential Cell Counter - Product Code GKZ
ProductCELL-DYN Sapphire, 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-- 08H00-01/42297AZ, 42909AZ, 42080AZ, 42410AZ
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		Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionProduct 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 Commerce69 units total
DistributionWorldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
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