VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures to...
FDA Recall #Z-0845-2021 — Class II — December 15, 2020
Product Description
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
Recalling Firm
Ortho Clinical Diagnostics Inc — Raritan, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
US=9802; OUS: 1298 Total: 11,100
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.
Code Information
All Current, Future and Past Lots UDI: 10758750031771
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated