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.
Reported: June 24, 2015 Initiated: November 7, 2014 #Z-1816-2015
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 7 Viper LT Systems
- Distribution
- Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton Dickinson & Co.. Units affected: 7 Viper LT Systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1816-2015.
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