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U.S. Department of Health and Human Services

Class 2 Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer

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 Class 2 Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzersee related information
Date Initiated by FirmJanuary 15, 2008
Date PostedApril 24, 2008
Recall Status1 Terminated 3 on December 23, 2010
Recall NumberZ-1165-2008
Recall Event ID 46368
510(K)NumberK051215 
Product Classification Differential Cell Counter - Product Code GKZ
ProductCELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
Code Information All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".   
FEI Number 2919069
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		Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.
FDA Determined
Cause 2		Process control
ActionOn January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.
Quantity in Commerce2,746 syringes were distributed.
DistributionWorldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
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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