Reported May 4, 2016 · Terminated

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Roche Molecular Systems, 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: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733

Is this the product you have?

  • Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Lot codes and dates
  • Material Number - IVD5401062001
Amount recalled
6,939 pieces

Where it was sold

  • Nationwide

Why it was recalled

The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

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 May 25, 2017 · Data as of Sep 19, 6:07 PM UTC

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