Device 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.
Z-1816-2015
Product summary
- Event
- Event 70164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 Viper LT Systems
- Official record key
device-enforcement:Z-1816-2015
Official wording
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.
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.
Distribution pattern: Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
Derived failure modes
-
Unknown
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.