BD Viper LT System Recalled for Potential False Positive Diagnostic Results
Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential false positive diagnostic results for sexually transmitted infections, which poses a risk of harm through incorrect medical management, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling seven units of the BD Viper LT System, catalog number 442839. This recall applies specifically to systems used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay.
The recall is being issued because of the potential for false positive results for Chlamydia trachomatis and Neisseria gonorrhoeae when processing these specific assays on the affected instruments. The affected serial numbers are VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, and VLT0033.
The affected units were distributed worldwide to the United States (specifically the state of Louisiana), Hong Kong, Austria, China, France, and the United Kingdom. Users of these in vitro diagnostic devices should contact Becton Dickinson & Co. for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distributed in 1 state:
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