DeviceClearance

Recall Z-1215-2013— Becton Dickinson & Co.

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-02-08, terminated 2013-05-13. It names 4 FDA 510(k) clearances: K091730, K090971, K090827 and 1 more. Product: 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.. Reason: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits..

Recalling firm
Becton Dickinson & Co.
Classification
Class II
Status
Terminated
Initiated
2013-02-08
Terminated
2013-05-13
Firm location
Sparks, MD, United States

510(k) clearances named in this recall

4 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

Data sourced from openFDA. This site is unofficial and independent of the FDA.