FDA-Device2017-04-19Class II
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Roche Diagnostics Corporation
Hazard
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.
Sold states
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Affected count
45
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1764-2017Don't want to check this manually?
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