Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Recalled by Roche Diagnostics Corporation Due to Roche Diagnostics Corp. initiated a voluntary correction because...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Quantity: 45
Why Was This Recalled?
Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.
Where Was This Sold?
This product was distributed to 16 states: AL, AR, CA, IL, IN, IA, LA, MA, MI, MO, NE, NJ, OH, PA, SC, TX
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report