BD Viper LT software recall: Software Issue
BD Viper LT software, version 3.00H
Why was BD Viper LT software 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
- Product
- BD Viper LT software, version 3.00H
- Recalling firm
- Bd Diagnostic
- Quantity
- 2
- Distribution
- 2 US customers, 0 Ex-US regions, and 0 distributors 0.
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)