Reported Sep 23, 2020 · Terminated
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track 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?
- Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical
- Chemistry Test Systems - Product UsageThe FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance
- Lot codes and dates
- Serial NumbersUS:
AP2.0111AP2.0137AP2.0190AP2.0191AP2.0290AP2.0296AP2.0321AP2.0322AP2.0349AP2.0385AP2.0398
- OUS
AP2.0111AP2.0113AP2.0143AP2.0170AP2.0225AP2.0242AP2.0250AP2.0259AP2.0265AP2.0270AP2.0285AP2.0295AP2.0316AP2.0350AP2.0382AP2.0388AP2.0389AP2.0390AP2.0392AP2.0448APT.0058APT.0065
- Serial NumbersUS:
- Amount recalled
- 10 US and 22 OUS
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
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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