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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Event Detail

Event ID 68271
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: US Nationwide including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. Software Version 2.7 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000102 through J34002323; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers:  34000337,  34001840,  34000316,  34001389, 34001317,  34000538,  34000552,  34000360,  34000451,  34000833,   34001572,  34000193,  34001633,  34000851,  34001345,  34001396, 34001809,  34001897,  34001240,  34001612,  34001311,  34000212, 34001472,  34001172,  34001390,  34000557,  34000893,  34001297, 34001378,  34001218,  34000318,  34000596,  34000497,  34000495, 34000529,  34000478,  34001569,  34001243,  34001504,  34000947, 34001422,  34000805,  34000631,  34001248,  34001251,  34000601, 34001274,  34001668,  34001850,  34001379,  34000133,  34000642, 34001626. Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Domestic - 597 units, Foreign - 1381 units Z-1736-2014
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912 Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Domestic - 835 units, Foreign - 921 units Z-1735-2014
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403 Class II Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected are VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH Domestic - 82, Foreign - 213 units Z-1734-2014
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