The Recall Desk
HighFDA (Devices)·Z-1763-2017·Announced 2017-04-19

Roche Recalls Cobas 8100 Modules Due to Potential Sample Spillage

Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a software issue can cause rack crashes and sample spillage, posing a risk of exposure to infectious material.

What this means for you

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 risk-of-harm product (exposure to infectious material) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Roche Diagnostics Corporation is voluntarily recalling 45 units of the Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx. The recall was initiated because a rack crash may occur on the affected modules, as well as uni-directional reformatter (URF) modules with the same software version, specifically when rack buffering is activated and the rack buffer is completely full.

This issue can lead to sample spillage, which poses a potential risk to operators and laboratory staff due to exposure to potentially infectious material. Additionally, the spillage can cause cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.

The affected units were distributed domestically in Massachusetts, Indiana, Alabama, Ohio, Missouri, Nebraska, Louisiana, California, Iowa, New Jersey, Arkansas, Pennsylvania, South Carolina, Illinois, Texas, and Michigan. No foreign distribution is reported. Users should contact Roche Diagnostics for instructions on how to proceed with the correction.

The recalled product

Product
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Manufacturer
Roche Diagnostics Corporation
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
45

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Roche Diagnostics Corporation

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