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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 65051
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 2013-04-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267. Class II Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. 13,751 Z-0517-2014