Becton Dickinson & Co.: Medical Device Recall in 2013 - (Recall #: Z-1215-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 8, 2013

Date Posted: May 15, 2013

Recall Number: Z-1215-2013

Event ID: 64444

Reason for Recall:

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

Status: Terminated

Product Quantity: 77 kits

Code Information:

Lot No./Exp. Date: 2237214 / 2013-10-31.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated