Z-0525-2014Class II

VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems...

Name: Z-0525-2014 VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems...
Creator: Ortho-Clinical Diagnostics
Published: 2013-10-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-10-09 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600... on 2013-10-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0525-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Posted: 2013-12-17
Terminated: 2018-05-17
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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 code: LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm, Ortho Clinical Diagnostics, sent a "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated October 9, 2013 to their clients/customers informing them of a shift in results that may be observed when performing patient sample correlation tests between VITROS CA 125 II Calibrators and Reagent Packs. The letter described the product, problem and actions to be taken. The customers were informed that it is acceptable to continue using any remaining inventory until its expiration date providing that quality control results are within acceptable limits (Note: Lots 1220 and 1230 are expired). The customers were also instructed to consider the need to review patient results using the affected lot(s). If you suspect that a previously reported result may have been affected, provide this information to your Laboratory Medical Director and the requesting physician or health care provider so that appropriate actions may be taken for the patients; Complete and return the attached Confirmation of Receipt form no later than October 18, 2013 via FAX TO: Ortho Clinical Diagnostics at 1-888-557-3759 or 1-585-453-4110, and Forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: 601 units
Distribution: 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.
Product codes and lots: product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0525-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code LTK

K983875Class IIVitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent PackOrtho-Clinical Diagnostics, Inc. / cleared 1999-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)