U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
real time Nucleic acid amplification system - Product Code OOI
원인
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.
조치
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.