Z-1866-2017 Class II Terminated
FDA device recall Z-1866-2017 was initiated by Bd Diagnostic on December 14, 2015 and is designated Class II. 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 t… The recall status is terminated (terminated April 19, 2017). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- December 14, 2015
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
BD Viper LT software, version 3.00H
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.
Distribution Pattern
2 US customers, 0 Ex-US regions, and 0 distributors 0.
Code Information
Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H