Z-1816-2015 Class II Terminated
FDA device recall Z-1816-2015 was initiated by Becton Dickinson & Co. on Nov 7, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 9, 2016). Affected quantity: 7 Viper LT Systems.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2015
- Initiation Date
- Nov 7, 2014
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 Viper LT Systems
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.
Distribution Pattern
Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
Code Information
Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1816-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026