Roche Molecular Systems, Inc.: cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

Is my product affected?

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

• UPC 05200881001

Check against the official notice below — it lists the full affected range.

What happened

Roche Molecular Systems is recalling 425 cobas® 4800 system z480 instruments distributed nationwide that use software version 1.1.1. In rare instances, these instruments have generated channel-shifted results where test signals are incorrectly reported in wrong channels—channel 1 results appear as channel 2, channel 2 as channel 3, channel 3 as channel 4, and channel 4 as channel 1. This affects the accuracy of assay results produced by the automated nucleic acid isolation system.

The recall applies to all lot and serial numbers of the cobas® 4800 system with Material Number 05200881001 running software version 1.1.1. According to the recall record provided, no specific remedy or consumer action is specified.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: Nationwide Distribution. Quantity: 425 instruments Lot/code info: Material Number 05200881001 - all lot/serial numbers.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls