Home / Recalls / Medical Devices
Roche Diagnostics Corporation recalls Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Recalled April 19, 2017 · FDA recall Z-1764-2017 · Roche Diagnostics
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. · FDA Class II
Units
45
Sold at
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Description
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.
Product
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →