PlainRecalls
FDA Devices Moderate Class II Terminated

Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module

Reported: January 1, 2014 Initiated: May 6, 2013 #Z-0561-2014

Product Description

Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module

Reason for Recall

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

Details

Units Affected
17,719
Distribution
US Nationwide and OUS.
Location
Newark, DE

Frequently Asked Questions

What product was recalled?
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 17,719.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0561-2014.