Device product
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Z-1578-2016
Product summary
- Event
- Event 73680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,939 pieces
- Official record key
device-enforcement:Z-1578-2016
Official wording
Reason: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Code information: Material Number - IVD: 5401062001
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.