Inpeco S.A. Via San Gottardo 10 Lugano Switzerland Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Brand
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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Inpeco S.A. Via San Gottardo 10 Lugano Switzerland is recalling Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: due to In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error rec. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent: Medical Device Correction dated 03/30/2020 were sent to customers. The impacted modules are the Aliquoter Modules (Inpeco Part Number FLX-212) with a firmware version prior to the following: AQMb_3-3-0.H86; AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86; xAQMb_1-1-0.elf; Action to be taken by the user To avoid the risk of contamination take the following precaution: 1) Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory guidelines considering that it may be diluted. 2) Call Service Assistant in case the frequency of the Clot Detection Error increases (more than 5 consecutive Clot Detection Errors). Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation CHeck form" attached to this letter with 15 days directly at the email address specified in the email communication. Contact reference person: FOr any clarificatino you may need, do not hesitate to ocntact: Eva Balzarotti - REgulatory Affairs Manager E-mail: regulatory.affairs@inpeco.com Phone: (+41) 91 9118 224
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026