Roche Molecular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0490-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

Product Classification:

Class II

Date Initiated: July 16, 2012

Date Posted: December 19, 2012

Recall Number: Z-0490-2013

Event ID: 63312

Reason for Recall:

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Status: Terminated

Product Quantity: 855 units.

Code Information:

Device-associated diagnostic software

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated