Z-1578-2016 Class II Terminated
FDA device recall Z-1578-2016 was initiated by Roche Molecular Systems, Inc. on March 3, 2016 and is designated Class II. Reason for recall: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. The recall status is terminated (terminated May 25, 2017). Affected quantity: 6,939 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 3, 2016
- Termination Date
- May 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,939 pieces
Product Description
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Reason for Recall
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Distribution Pattern
Nationwide Distribution
Code Information
Material Number - IVD: 5401062001