FDA Device recall Z-1866-2017
BD Viper LT software, version 3.00H
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of BD Viper LT software, version 3.00H by Bd Diagnostic, citing 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 decreas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1866-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-14 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bd Diagnostic |
| Distribution | n/a |
Product
BD Viper LT software, version 3.00H
Reason
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.
Identifiers
| code_info | Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1866-2017%22
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