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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