cobas¿ 4800 system z480 instrument. Integrates fully recall
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Why was cobas¿ 4800 system z480 instrument. Integrates fully 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number 05200881001 - all lot/serial numbers.
- Product
- cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 425 instruments
- Distribution
- Nationwide Distribution.
- Recall date
- May 29, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)