Ortho-Clinical Diagnostics: Medical Device Recall in 2019 - (Recall #: Z-1936-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 8, 2019

Date Posted: July 10, 2019

Recall Number: Z-1936-2019

Event ID: 82784

Reason for Recall:

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Status: Terminated

Product Quantity: 3889 units

Code Information:

All lots

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated