Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a functional defect (delayed processing) affecting device operation rather than patient safety, consistent with a precautionary operational recall.
Plain-English summary
Inpeco S.A. is recalling firmware versions COBASa_2.2.0 and COBASa_2.3.0 used in the Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM). The affected firmware may lead to delayed sample tube processing in this laboratory automation system, which is designed to automate pre-analytical and post-analytical sample handling.
The recall affects one unit in the United States (located in Massachusetts) and 14 units distributed internationally in Austria, Belgium, Denmark, Italy, Norway, and Spain. The affected hardware version is FLX-247-00 with specific serial numbers identified in the recall notice.
Laboratory administrators and personnel operating affected systems should contact Inpeco S.A. for instructions on obtaining a firmware update or other corrective measures to address potential processing delays.
The recalled product
- Product
- Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
- Manufacturer
- Inpeco S.A.
- Hazard
- delayed-processing
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27