Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1348-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

Product Classification:

Class II

Date Initiated: February 16, 2016

Date Posted: April 13, 2016

Recall Number: Z-1348-2016

Event ID: 73429

Reason for Recall:

The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

Status: Terminated

Product Quantity: 2,101 Total units (1,043 domestically & 1,058 internationally)

Code Information:

Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated