Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-1734-2014)

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 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: April 10, 2014

Date Posted: June 18, 2014

Recall Number: Z-1734-2014

Event ID: 68271

Reason for Recall:

Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Status: Terminated

Product Quantity: Domestic - 82, Foreign - 213 units

Code Information:

Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403

Distribution Pattern:

Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated