Z-0845-2021 Class II Terminated
FDA device recall Z-0845-2021 was initiated by Ortho Clinical Diagnostics Inc on December 15, 2020 and is designated Class II. Reason for recall: Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides The recall status is terminated (terminated July 27, 2021). Affected quantity: US=9802; OUS: 1298 Total: 11,100.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 15, 2020
- Termination Date
- July 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US=9802; OUS: 1298 Total: 11,100
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
Distribution Pattern
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