FDA Enforcement
Class II
Terminated
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
Recall: Z-0845-2021
·
Reported January 20, 2021
Enforcement
- Recall Number
- Z-0845-2021
- Event ID
- 87019
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho Clinical Diagnostics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 20, 2021
- Initiation Date
- December 15, 2020
- Classification Date
- January 12, 2021
- Termination Date
- July 27, 2021
- Address
- 1001 US Highway 202, N/A, Raritan, NJ, 08869-1424, United States
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
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Code Info
All Current, Future and Past Lots UDI: 10758750031771
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.
Quantity
US=9802; OUS: 1298 Total: 11,100