Z-1936-2019 Class II Terminated
FDA device recall Z-1936-2019 was initiated by Ortho-Clinical Diagnostics on April 8, 2019 and is designated Class II. Reason for recall: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. The recall status is terminated (terminated November 12, 2020). Affected quantity: 3889 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- November 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3889 units
Product Description
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Reason for Recall
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Distribution Pattern
US Nationwide Distribution
Code Information
All lots