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U.S. Department of Health and Human Services

Class 2 Device Recall White Blood Cell (WBC) ReagentPart A used with the CELLDYN 4000 and CELLDYN Sapphire Systems

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  Class 2 Device Recall White Blood Cell (WBC) ReagentPart A used with the CELLDYN 4000 and CELLDYN Sapphire Systems see related information
Date Initiated by Firm December 19, 2007
Date Posted May 14, 2008
Recall Status1 Terminated 3 on July 02, 2008
Recall Number Z-1103-2008
Recall Event ID 46296
510(K)Number K961439  K051215  
Product Classification Red cell lysing reagent - Product Code GGK
Product White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
Code Information Lot Numbers: 51749i2, 51754i2 and 56675i2.
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		 Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
FDA Determined
Cause 2		 Material/Component Contamination
Action Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.
Quantity in Commerce Product was distributed in the follow amounts: 1,199 botttles of lot code 51749i2; 1,150 bottles of lot code 1574i2, 1,150 bottles of lot code 56675i2
Distribution Worldwide Distribution including USA states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI and WV, and countries of: Argentina, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Singapore, South Korea and Venezuela.
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.
510(K) Database 510(K)s with Product Code = GGK and Original Applicant = ABBOTT DIAGNOSTICS
510(K)s with Product Code = GGK and Original Applicant = ABBOTT LABORATORIES
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