FDA recall Z-1936-2019

Product

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

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-04-08

Report date

2019-07-10

Termination date

2020-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1936-2019