The Recall Desk

FDA (Devices) recall action 91950

Inpeco S.A. recalled 5 products on 2023-05-10

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2023-05-10
Critical
0
Units
—

Why these products were recalled

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 t…

The agency’s own wording, quoted from the enforcement report.

1–5 of 5

  • HighFDA (Devices)··2023-05-10

    Laboratory Automation System Firmware May Misidentify Patient Samples

    Inpeco laboratory automation systems' firmware can misassociate patient samples, potentially leading to incorrect electrolyte test results. The defect is rare but could cause serious medical consequences if results are misidentified or delayed.

    Product
    PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
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    0 states
  • HighFDA (Devices)··2023-05-10

    Laboratory Automation Module Firmware May Cause Sample Misidentification

    Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.

    Product
    Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
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    0 states
  • HighFDA (Devices)··2023-05-10

    Laboratory Automation System Firmware May Misassociate Patient Samples

    Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.

    Product
    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 F
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    0 states
  • HighFDA (Devices)··2023-05-10

    Laboratory automation module firmware may cause sample misidentification

    A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.

    Product
    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
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    0 states
  • HighFDA (Devices)··2023-05-10

    Laboratory automation system firmware recalled for sample mis-identification

    Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

    Product
    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
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    0 states