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 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 27, 2014 · Data as of Sep 19, 4:50 PM UTC

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