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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65706
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 2013-07-01
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients. TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiation date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14. Class II Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing. 5423 Z-1924-2013
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