Roche Recalls cobas 4800 Systems Due to Rare Channel Shift Errors
Roche Molecular Systems is recalling 425 cobas 4800 systems because rare channel-shift errors may cause test results to be reported in the wrong channel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software error could lead to inaccurate diagnostic results. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 425 cobas 4800 systems (z480 instruments) distributed nationwide. The recall is due to a rare issue where channel-shifted results may be generated when using version 1.1.1 of the system software.
In these rare instances, raw data review indicates that all signals are shifted by one channel. Specifically, channel 1 results are reported as channel 2, channel 2 results as channel 3, channel 3 results as channel 4, and channel 4 results as channel 1. This error affects the accuracy of the reported test data.
The recalled instruments are identified by Material Number 05200881001 and include all lot and serial numbers. Healthcare facilities and laboratories using these instruments should contact Roche Molecular Systems for further instructions on how to proceed.
The recalled product
- Product
- cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Material Number 05200881001 - all lot/serial numbers.
Distribution
Distributed nationwide across the United States.
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