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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 65131
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 2013-05-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide and OUS.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11 Class II Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected lot of Chemistry Wash is placed on the instrument following an unaffected lot, a negative bias will be seen on CTN1, LTN1, TSH, PBNP and LPBN. A positive bias will be seen on FT4; 2 - If any of these assays are calibrated using an affected lot of Chemistry Wash, QC should return within range; but when a subsequent unaffected Chemistry Wash lot is placed into use, a positive bias will be seen on CTN1, LTN1, TSH, PBNP and LPBN. A negative bias will be seen on FT4. 17,719 Z-0561-2014
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