FDAFDA · Food and drugs·Recall number Z-1866-2017
BD Viper LT software, version 3.00H
Published April 26, 2017 · Recall initiated: December 14, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bd Diagnostic
- Distributor
- 2 US customers, 0 Ex-US regions, and 0 distributors 0.
- Lot
- Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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