BD Viper LT software, version 3.00H recallZ-1866-2017 · Bd Diagnostic · initiated Dec 14, 2015
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Diagnostic or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
FDA root cause category: Software design
What the company is doing
Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.
Recall details
- Recall number
- Z-1866-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 14, 2015
- Posted by the FDA
- Apr 4, 2017
- Recalling firm
- Bd Diagnostic
- Quantity
- 2
- Product code
- OOI
- FDA submissions
- K140447
- Distribution
- 2 US customers, 0 Ex-US regions, and 0 distributors 0.
Product description
BD Viper LT software, version 3.00H
Code information (models, lots, serial numbers)
Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
Other devices under the same FDA submission
1 device cleared under K140447 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Viper™ LT System 442839Becton, Dickinson And Company · real time Nucleic acid amplification system37 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page