FDAFDA · Food and drugs·Recall number Z-1346-2013
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Published May 29, 2013 · Recall initiated: April 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Material Number 05200881001 - all lot/serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.