FDA Enforcement
Class III
Terminated
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Recall: Z-0807-2018
·
Reported March 7, 2018
Enforcement
- Recall Number
- Z-0807-2018
- Event ID
- 78724
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho Clinical Diagnostics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- March 7, 2018
- Initiation Date
- July 10, 2017
- Classification Date
- March 1, 2018
- Termination Date
- August 6, 2020
- Address
- 1001 US Highway 202, N/A, Raritan, NJ, 08869-1424, United States
Description
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
Code Info
Lot K4852, Expiration 22 Feb 2018
Distribution
Worldwide
Quantity
10,021 units