Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk
Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.
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 risk of exposure to potentially infectious material and cross-contamination, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is voluntarily recalling 45 units of the Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx. The recall is initiated because a rack crash may occur on these modules 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. Laboratory staff should stop using the affected modules and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 45
Distribution
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.
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