Inpeco recalls Vesmatic Cube 80 Interface Modules that may mis-associate sample IDs causing incorrect electrolyte results. This could lead to inappropriate treatment or failure to treat abnormal results, risking serious health issues including cardiac arrhythmias and death.
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 recalls Vesmatic Cube 80 Interface Modules that may mis-associate sample IDs, leading to incorrect electrolyte test results. This could cause inappropriate treatment of normal results or failure to treat abnormal results, potentially causing serious health risks like cardiac arrhythmias or death.
The firmware may misidentify sample tubes during testing, causing the system to process the wrong sample as the correct one. This leads to incorrect electrolyte results, which can cause serious health issues like cardiac arrhythmias or death if not corrected.
Laboratory technicians and healthcare providers using the Vesmatic Cube 80 Interface Module for patient testing are most at risk. Patients receiving tests from this system could experience incorrect electrolyte results.
Check for the Vesmatic Cube 80 Interface Module (VMC) with brand names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). The product has part numbers 72747000.A and UDI codes starting with FlexLab 07640172340004, Accelerator a3600 07640172341001, or Aptio Automation 07640172342008.
Inpeco has released a Technical Service Bulletin with instructions for field service engineers to update the firmware. This fix addresses the misidentification issue.
Incorrect electrolyte results could lead to inappropriate treatment of normal results or failure to treat abnormal results, potentially causing serious health issues like cardiac arrhythmias or death.
Check for the product with brand names FlexLab (FLX), Accelerator a3600 (ACP), or Aptio Automation (AP2). The part numbers are 72747000.A and UDI codes starting with FlexLab 07640172340004, Accelerator a3600 07640172341001, or Aptio Automation 07640172342008.
The hazard can lead to incorrect electrolyte results, which may cause serious health issues including cardiac arrhythmias or death if not corrected. However, the specific event requires a rare sequence of conditions to occur.
We’ve drafted a message you can send Inpeco to request your refund or repair — edit it as you like.
Subject: Recall Z-1562-2023 — Inpeco Inpeco Hello, I own a Inpeco that is covered by recall Z-1562-2023 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.
