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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 62833
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City Newark
State DE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012 Class III Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. 583 cartons Z-0253-2013