Medical device recalls Moderate risk

Roche Molecular Systems, Inc. recalls Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Recall date
March 3, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1578-2016
FDA classification
Class II
Brand / firm
Roche Molecular Systems, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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