Device product
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
Z-2874-2020
Product summary
- Event
- Event 86070
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534
- Official record key
device-enforcement:Z-2874-2020
Official wording
Reason: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Code information: All Current, Future and Past Lots UDI: 10758750004829, 10758750009398
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Derived failure modes
-
Unknown
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides