Inpeco recalls FlexLab and Accelerator laboratory automation systems due to firmware that may cause incorrect electrolyte test results, potentially leading to serious health issues if not corrected.
Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.
Inpeco is recalling FlexLab and Accelerator laboratory automation systems because outdated firmware can cause incorrect electrolyte test results. This could lead to improper treatment or missed critical health issues, such as cardiac problems or death.
The system's firmware may misidentify sample tubes during a specific brief window when a tube is released. This can cause incorrect test results for electrolytes like potassium, sodium, and chloride, which are critical for heart function, nerve signaling, and fluid balance. Abnormal levels can cause weakness, cardiac issues, or even death.
Laboratory technicians and healthcare facilities using Inpeco's FlexLab or Accelerator systems are most at risk. Patients receiving tests from these systems could experience incorrect electrolyte results.
Check if your lab uses the FlexLab (FLX), Accelerator, or Aptio Automation systems with part numbers 72747000.A or UDI codes starting with FlexLab 07640172340004, Accelerator a3600 07640172341001, or Aptio Automation 07640172342008. All firmware versions are affected.
Inpeco will send field service engineers to update the firmware on your system. This fix requires professional installation.
Yes. Incorrect electrolyte results can lead to cardiac arrhythmias, respiratory depression, or death if not addressed.
Check your system's part number or UDI code. Affected models include FlexLab (FLX), Accelerator, and Aptio Automation with specific part numbers listed in the recall notice.
Yes. Inpeco has released a technical service bulletin for firmware updates, which field service engineers will perform.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-1561-2023 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-1561-2023 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.
