Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-0967-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. 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: November 19, 2014

Date Posted: January 21, 2015

Recall Number: Z-0967-2015

Event ID: 69830

Reason for Recall:

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Status: Terminated

Product Quantity: 658 total: USA - 144, Foreign - 514

Code Information:

Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Distribution Pattern:

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated