Roche Molecular Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1346-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

Product Classification:

Class II

Date Initiated: April 1, 2013

Date Posted: May 29, 2013

Recall Number: Z-1346-2013

Event ID: 64930

Reason for Recall:

In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported

Status: Terminated

Product Quantity: 425 instruments

Code Information:

Material Number 05200881001 - all lot/serial numbers.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated