Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-0652-2019)

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¿ 3600 Immunodiagnostic System, Version 3.3.1 & 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-0652-2019

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: 682

Code Information:

Product Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated