Company:Roche Diagnostics Corporation
Date of Enforcement Report 4/192017
Class lI:
PRODUCT
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Recall Number Z-1763-2017
REASON
“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 (URF) 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.”
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corporation, Indianapolis, IN on 3/1/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
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