BD Viper LT Software Recall Due to Inaccurate Test Results
BD Diagnostic is recalling BD Viper LT software version 3.00H because it generates lower-than-expected RFU values, which may impact 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 involves a medical device software defect that can impact test results, representing a risk of harm where injury has not yet been reported.
Plain-English summary
BD Diagnostic is recalling BD Viper LT software, version 3.00H, due to confirmed reports of lower than expected Relative Fluorescence Unit (RFU) values generated on customer BD Viper LT Systems after the software installation. The affected catalog numbers are 443157, 443153, 443155, 443156, 442947, and 443902.
The recall is necessary because the decreased RFU values cause results to approach the assay cutoff threshold, which has the potential to impact test results. This software was distributed to two US customers.
Customers should contact BD Diagnostic for further instructions regarding the software update or replacement.
The recalled product
- Product
- BD Viper LT software, version 3.00H
- Manufacturer
- Bd Diagnostic
- Hazard
- Affected units
- 2
Distribution
Distribution scope not specified by the agency.
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