Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-0968-2015)

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 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

Product Classification:

Class II

Date Initiated: November 19, 2014

Date Posted: January 21, 2015

Recall Number: Z-0968-2015

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: 339 Total: USA - 102, Foreign - 237

Code Information:

Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (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