VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and pl...
FDA Recall #Z-0844-2021 — Class II — December 15, 2020
Product Description
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
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= 223,788 ; OUS:=168,120 Totlal: 491,908
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: 10758750004850
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated