Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-0651-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

Product Classification:

Class II

Date Initiated: October 19, 2018

Date Posted: December 26, 2018

Recall Number: Z-0651-2019

Event ID: 81563

Reason for Recall:

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

Status: Terminated

Product Quantity: 1105

Code Information:

Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated