Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BD Viper LT software, version 3.00H

FDA Recall Z-1866-2017 · Posted 2017-04-04

Recalling FirmBd Diagnostic
Recall StatusTerminated
Product CodeOOI
Date Initiated2015-12-14
Date Terminated2017-04-19
Product Quantity2

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.

Firm Action

Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.

Root Cause

Software design

Distribution Pattern

2 US customers, 0 Ex-US regions, and 0 distributors 0.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑