Ortho-Clinical Diagnostics: Medical Device Recall in 2012 - (Recall #: Z-2068-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

Product Classification:

Class II

Date Initiated: May 21, 2012

Date Posted: August 1, 2012

Recall Number: Z-2068-2012

Event ID: 61910

Reason for Recall:

software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

Status: Terminated

Product Quantity: 1387

Code Information:

Version 2.0 & Below

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated