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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description 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.
Recall Number Z-1215-2013
Classification Class II
Code Info Lot No./Exp. Date: 2237214 / 2013-10-31.
Product Distributed Qty 77 kits
Reason For Recall Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

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 Letter
Distribution Pattern Distributed in the states of CA, FL, GA, NJ, and TX.
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