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U.S. Department of Health and Human Services

Class 3 Device Recall Directigen (TM) EZ RSV

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  Class 3 Device Recall Directigen (TM) EZ RSV see related information
Date Initiated by Firm December 15, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 21, 2004
Recall Number Z-0373-04
Recall Event ID 27995
510(K)Number K022133  
Product Classification Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus - Product Code GQG
Product Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
Code Information lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Ms. Jody Hoffmann
410-316-4098
Manufacturer Reason
for Recall
Diagnostic test kit may exhibit false positive results.
FDA Determined
Cause 2
Other
Action The recalling firm notified consignees by fax, e-mail and letters 12/15/03. The letter advised of the false positive test results and requested end users to discontinue use and discard remaining packages for replacement. Consignees were requested to return response form.
Quantity in Commerce 600 kits
Distribution Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
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 = GQG and Original Applicant = BECTON DICKINSON & CO.
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