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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Emerald Diluent Reagent

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  Class 2 Device Recall CELLDYN Emerald Diluent Reagent see related information
Date Initiated by Firm September 30, 2010
Date Posted March 17, 2011
Recall Status1 Terminated 3 on April 07, 2011
Recall Number Z-1668-2011
Recall Event ID 56968
510(K)Number K081495  
Product Classification Differential Cell Counter - Product Code GKZ
Product Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02,
Product is manufactured and distributed by
Abbott Diagnostics Division, Santa Clara. CA

Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
Code Information Lot Number: 4350, Expiration Date: June 30, 2012
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact Kelly Duffy
408-982-4800
Manufacturer Reason
for Recall		 The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.
FDA Determined
Cause 2		 Error in labeling
Action Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.
Quantity in Commerce 322 units
Distribution Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
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 = GKZ and Original Applicant = ABBOTT LABORATORIES
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