FDA Enforcement
Class II
Terminated
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
Recall: Z-0844-2021
·
Reported January 20, 2021
Enforcement
- Recall Number
- Z-0844-2021
- 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 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
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: 10758750004850
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= 223,788 ; OUS:=168,120 Totlal: 491,908