Reported Dec 27, 2023 · Ongoing
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to…
Inpeco S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano, N/A · N/A
Is this the product you have?
- 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 versionsFLX-247-00
- Firmware versions
COBASa_2.2.0COBASa_2.3.0
- Lot codes and dates
- FlexLab UDI-DI07640172340004
- Hardware versionsFLX-247-00
- Firmware versions
COBASa_2.2.0COBASa_2.3.0
- Serial Number USFLX.0208
- Serial Numbers OUSSerial Number
FLX.0116FLX.0165FLX.0178FLX.067FLX.0127FLX.0128FLX.0150FLX.0154FLX.012FLX.0121FLX.0132FLX.031FLX.048FLX.049
- Amount recalled
- 1 unit US: 14 units OUS
Where it was sold
- Nationwide
- MA
Why it was recalled
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
This product could cause temporary or reversible health problems — stop using it.
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