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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64444
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in the states of CA, FL, GA, NJ, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. Lot No./Exp. Date: 2237214 / 2013-10-31. Class II Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. 77 kits Z-1215-2013