Inpeco recalls Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Modules due to potential mis-association of sample IDs, which could lead to incorrect or delayed lab results. Affected units have specific serial numbers.
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
Inpeco is recalling certain Aptio Automation systems that use Sysmex XN-9000/XN-9100 Interface Modules. The recall is because the firmware might mis-associate sample IDs, causing incorrect or delayed lab results. This could affect the accuracy of critical medical tests.
The firmware in the Interface Module and Track to Rack Module could mis-associate sample IDs. This might lead to incorrect lab results or delayed testing, which could impact patient care if the tests are critical.
Healthcare facilities using the recalled Aptio Automation systems with specific serial numbers are most at risk. Patients relying on these systems for lab tests may experience inaccurate results.
Check if your system has the serial numbers listed: US serials starting with AP2.0 and OUS serials starting with AP2.0 or APT. The affected systems are the Aptio Automation with Sysmex XN-9000/XN-9100 Interface Modules (FLX-290-10, FLX-290-20) and Track to Rack Module (FLX-295-10).
Identify if your system has the listed serial numbers: US serials starting with AP2.0 and OUS serials starting with AP2.0 or APT.
The firmware in the Interface Module and Track to Rack Module may mis-associate sample IDs, leading to incorrect or delayed lab results.
Check if your system has serial numbers starting with AP2.0 (US) or AP2.0 or APT (OUS). Affected models include the Aptio Automation with Sysmex XN-9000/XN-9100 Interface Modules (FLX-290-10, FLX-290-20) and Track to Rack Module (FLX-295-10).
No action is needed if your system does not have the listed serial numbers.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-2975-2020 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-2975-2020 from Inpeco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
