FDA-Device2016-05-04Class II
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Roche Molecular Systems, Inc.
Hazard
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Sold states
Nationwide Distribution
Affected count
6,939 pieces
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1578-2016Don't want to check this manually?
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