Reported Jun 19, 2013 · Terminated

Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining…

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. · 2040 Enterprise Blvd · West Sacramento, CA · 95691-3427

Is this the product you have?

  • Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Lot codes and dates
  • Lot
    • 2013-11-13
    • Exp 11/13/2013
Amount recalled
683 units

Where it was sold

  • Nationwide

Why it was recalled

The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.

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 Sep 17, 2013 · Data as of Sep 19, 6:54 PM UTC

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