Roche Molecular Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1578-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Product Classification:

Class II

Date Initiated: March 3, 2016

Date Posted: May 4, 2016

Recall Number: Z-1578-2016

Event ID: 73680

Reason for Recall:

The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

Status: Terminated

Product Quantity: 6,939 pieces

Code Information:

Material Number - IVD: 5401062001

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated