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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 3/4/8 Assay reagents for Sapphire

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 Class 2 Device Recall CELLDYN 3/4/8 Assay reagents for Sapphiresee related information
Date Initiated by FirmDecember 16, 2005
Date PostedFebruary 16, 2006
Recall Status1 Terminated 3 on April 13, 2006
Recall NumberZ-0527-06
Recall Event ID 34395
510(K)NumberK010953 
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
Code Information List Number: 07H22-01, lot numbers: 16328 and 29401
FEI Number 2919069
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
Manufacturer Reason
for Recall		T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
FDA Determined
Cause 2		Other
ActionThe firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
Quantity in Commerce871 units
DistributionNationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
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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