Inpeco S.A. has recalled 15 units of the Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM) due to a firmware defect. This interface module is part of the FlexLab Automation System used in clinical laboratories to manage sample tube processing. A firmware error in versions COBASa_2.2.0 and COBASa_2.3.0 can cause delays in how sample tubes are processed through the laboratory workflow. Affected units were distributed globally, including one unit in Massachusetts.
The firmware defect can lead to significant delays in processing medical samples, which could potentially delay critical laboratory test results for patients. Such delays may impact clinical decision-making or the timely administration of necessary treatments.
Manufacturer firmware correction and support
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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