Recall Z-1816-2015— Becton Dickinson & Co.

Name: FDA recall Z-1816-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-07

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2014-11-07, terminated 2016-05-09. It names one FDA 510(k) clearance: K140447. Product: BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.. Reason: Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Terminated: 2016-05-09
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K140447 — BD VIPER LT SYSTEMBecton, Dickinson and Company·cleared 2014-05-20

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 Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.

Reason for recall

Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.

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