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U.S. Department of Health and Human Services

Class 2 Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly

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  Class 2 Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly see related information
Date Initiated by Firm July 23, 2010
Date Posted November 29, 2010
Recall Status1 Terminated 3 on September 01, 2011
Recall Number Z-0489-2011
Recall Event ID 56775
Product Classification Counter, differential cell - Product Code GKZ
Product CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers;


CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02,
CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01,
CELL-DYN 4000 Vent Needle, List Number: 02H61-01,
CELL-DYN 4000 Accessory Kit, List Number: 01H20-01,
CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576,
CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101,
CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201;

Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
Code Information Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
Recalling Firm/
Manufacturer		 Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact Kelly E. Duffy
408-982-4800
Manufacturer Reason
for Recall		 The Vent Needle, which is built into the Vent Head Assembly on the CELL-DYN Sapphire Instrument and which is used directly on the CELL-DYN 4000 Instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
FDA Determined
Cause 2		 Process control
Action Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.
Distribution Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
Total Product Life Cycle TPLC 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.
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