Reported Apr 26, 2017 · Terminated
BD Viper LT software, version 3.00H
Bd Diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bd Diagnostic · 54 Loveton Circle Mc 912 · Sparks, MD · 21152
Is this the product you have?
- BD Viper LT software, version 3.00H
- Lot codes and dates
- Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
- Amount recalled
- 2
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.
This product could cause temporary or reversible health problems — stop using it.
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