Reported May 20, 2015 · Terminated

Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM,…

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 EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Lot codes and dates
  • Model numbers
    • D045912
    • D193440
    • D140066
  • Material Numbers
    • 10472176
    • 10636928
    • 10465412
    • 10461038
    • 10444828
    • 10444829
    • 10461849
    • 10461043
    • 10444837
    • 10444838
Amount recalled
17801

Why it was recalled

Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.

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 17, 2016 · Data as of Sep 19, 6:16 PM UTC

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