BD Viper LT software, version 3.00H
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Bd Diagnostic
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BD Viper LT software, version 3.00H
Product Codes/Lot Numbers:
Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1866-2017