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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 66496
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-09
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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: 680 0034; Lot numbers 1220, 1230, 1240, 1250 Class II 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. 601 units Z-0525-2014
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