The Recall Desk

Manufacturer

Inpeco S.A.

33 recalls in our database name Inpeco S.A. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
1
Most recent
2025-12-03

Of the 33 recalls from Inpeco S.A. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 33

  • HighFDA (Devices)·Z-0107-2026·2025-10-15

    FlexLab X system recalled over unevaluated blood sample integrity function

    Inpeco is recalling one FlexLab X system because the Sample Integrity Module's hemolysis, icterus and lipemia function has not been evaluated by the FDA.

    Product
    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0560-2024·2023-12-27

    Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing

    Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.

    Product
    Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2023·2023-05-10

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2023·2023-05-10

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2023·2023-05-10

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2023·2023-05-10

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2023·2023-05-10

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2022·2021-10-20

    Automation System Interface Module Firmware May Misassociate Test Results to Samples

    Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2021·2020-11-18

    Inpeco Aptio Automation System Recall for Potential Sample Dilution

    Inpeco S.A. is recalling 104 Aptio Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in th
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0433-2021·2020-11-18

    Inpeco Accelerator a3600 Aliquoter Module Recall for Sample Dilution Risk

    Inpeco S.A. is recalling 136 Accelerator a3600 Automation Systems with Aliquoter Modules due to a software error that may dilute samples with water, leading to erroneous test results.

    Product
    Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample proc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0432-2021·2020-11-18

    Inpeco FlexLab Automation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 93 FlexLab Automation Systems with Aliquoter Modules because a software error may cause samples to be diluted with water, leading to erroneous test results.

    Product
    FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processin
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2974-2020·2020-09-23

    Inpeco FlexLab 3.6 Automation Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling 8 FlexLab 3.6 Automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed clinical chemistry results.

    Product
    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Pos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2020·2020-06-10

    Inpeco FlexLab Augomation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 71 FlexLab Augomation Systems because a firmware error may dilute primary sample tubes with distilled water, potentially causing discrepant patient results.

    Product
    FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2020·2020-06-10

    Inpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk

    Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2020·2020-06-10

    Inpeco Aptio Automation System Recall for Firmware Error Recovery Defect

    Inpeco S.A. is recalling 61 Aptio Automation Systems because a firmware error recovery procedure may dilute primary sample tubes with distilled water.

    Product
    Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Safety Switch Delay

    Inpeco S.A. is recalling two Accelerator a3600 Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2114-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation

    Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.

    Product
    FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Ad
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical proces
    Category
    Medical Device
    Distribution
    Distributed nationwide