Ortho-Clinical Diagnostics: Medical Device Recall in 2019 - (Recall #: Z-1289-2019)

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¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Product Classification:

Class II

Date Initiated: February 20, 2019

Date Posted: May 15, 2019

Recall Number: Z-1289-2019

Event ID: 82311

Reason for Recall:

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

Status: Terminated

Product Quantity: 267 units

Code Information:

Serial Numbers: 36001160 & above UDI: 10758750002979)

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated