Reported Jan 1, 2014 · Terminated
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R)…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension(R) Chemistry Wash (RD701), Siemens Material
- Number (SMN) 10445052 Product UsageUsed in the Dimension(R) system with the heterogeneous module
- Lot codes and dates
Lot numbers RD23031exp 2013-04-29RD23111exp 2013-05-07RD23241exp 2013-05-19RD23311exp 2013-06-04and RD23461exp 2013-06-11
- Amount recalled
- 17,719
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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