FDA-Device2014-01-01Class II
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Siemens Healthcare Diagnostics, Inc.
Hazard
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 l
Sold states
US Nationwide and OUS.
Affected count
17,719
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2014Don't want to check this manually?
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