Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-2139-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).

Product Classification:

Class II

Date Initiated: July 7, 2014

Date Posted: August 13, 2014

Recall Number: Z-2139-2014

Event ID: 68790

Reason for Recall:

Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

Status: Terminated

Product Quantity: Domestic: 142, Foreign: 536

Code Information:

Serial Numbers J36000101 - J36000806 (J Numbers are analogous to Serial Numbers and for VITROS 3600 systems the J Numbers start with 3600XXXX)

Distribution Pattern:

Worldwide Distribution-USA (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