Z-2874-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- July 13, 2020
- Termination Date
- July 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534
Product Description
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)
Reason for Recall
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
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.
Code Information
All Current, Future and Past Lots UDI: 10758750004829, 10758750009398