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.
What this means for you
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.
Related recalls
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06