Z-0844-2021 Class II Terminated
FDA device recall Z-0844-2021 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= 223,788 ; OUS:=168,120 Totlal: 491,908.
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= 223,788 ; OUS:=168,120 Totlal: 491,908
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
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: 10758750004850