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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Recall Number Z-1736-2014
Classification Class II
Code Info 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.
Product Distributed Qty Domestic - 597 units, Foreign - 1381 units
Reason For Recall 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

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.
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