Reported Jun 10, 2020 · Ongoing
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical…
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?
- FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
- Lot codes and dates
- Serial Numbers
71 of 71 codes
FLX.008FLX.0105FLX.0106FLX.0107FLX.0113FLX.0114FLX.0115FLX.0116FLX.0118FLX.0119FLX.012FLX.0121FLX.0124FLX.0125FLX.0126FLX.0127FLX.0128FLX.0129FLX.0131FLX.0135FLX.0136FLX.0138FLX.014FLX.0140FLX.0141FLX.0143FLX.015FLX.0152FLX.0155FLX.0158FLX.0161FLX.0164FLX.017FLX.018FLX.0196FLX.020FLX.021FLX.022FLX.023FLX.027FLX.029FLX.030FLX.031FLX.032FLX.033FLX.037FLX.038FLX.039FLX.043FLX.044FLX.046FLX.047FLX.050FLX.051FLX.052FLX.056FLX.060FLX.064FLX.071FLX.072
- Serial Numbers
- Amount recalled
- 71 systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
This product could cause temporary or reversible health problems — stop using it.
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