Home / Recalls / Roche Molecular Systems, Inc. / Z-1578-2016

Z-1578-2016 Class II Terminated

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

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

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