Ortho-Clinical Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-0525-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).

Product Classification:

Class II

Date Initiated: October 9, 2013

Date Posted: December 25, 2013

Recall Number: Z-0525-2014

Event ID: 66496

Reason for Recall:

Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.

Status: Terminated

Product Quantity: 601 units

Code Information:

product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and 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