Reported May 29, 2013 · Terminated
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary…
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 Us Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
- Lot codes and dates
- Material Number 05200881001 - all lot/serial numbers.
- Amount recalled
- 425 instruments
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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