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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN

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 Class 2 Device Recall CELLDYNsee related information
Date Initiated by FirmJuly 25, 2007
Date PostedJanuary 04, 2008
Recall Status1 Terminated 3 on November 17, 2009
Recall NumberZ-0301-2008
Recall Event ID 45446
510(K)NumberK051215 
Product Classification Hematology Analyzer Syringe - Product Code GKZ
ProductAbbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )
Code Information Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
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		Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThis Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott
Quantity in Commerce302 units
DistributionWorldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Australia, Brazil, Chile, Germany, and Hong Kong.
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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