FDA recall Z-0845-2021

Ortho Clinical Diagnostics Inc · Class II · device

Product

VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293

Reason for recall

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

Distribution

Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.

Key facts

Status: Terminated
Initiation date: 2020-12-15
Report date: 2021-01-20
Termination date: 2021-07-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2021