—#122496

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).

FDA product code: LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K983875
Affected lot / code info: product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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.

Timeline

Recall initiated: 2013-10-09
Posted by FDA: 2013-12-17
Terminated: 2018-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122496. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.