The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1562-2023·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for laboratory automation system where firmware defect can cause sample misidentification, leading to incorrect electrolyte results that could cause serious patient harm. No illnesses, hospitalizations, or injuries have been reported. The defect requires specific concurrent failure conditions (sample release timing coinciding with divert gate malfunction), making it a theoretical risk scenario.

Plain-English summary

Inpeco S.A. has recalled the Vesmatic Cube 80 Interface Module (VMC) laboratory automation system, sold as FlexLab, Accelerator a3600, and Aptio Automation, affecting 245 units in the US with worldwide distribution.

The firmware controlling these systems can incorrectly associate sample identification numbers under specific conditions. This occurs only when the module simultaneously releases a sample tube while another sample tube fails to divert properly due to a divert gate malfunction. When this rare combination of events occurs, the system releases the wrong sample without generating an error message, causing the automation system to lose identification of the original sample.

Incorrect sample identification leads to incorrect test results for sodium, potassium, and chloride levels. These electrolyte imbalances can cause either inappropriate treatment of normal results or failure to treat abnormal results. Abnormal potassium levels can result in weakness, irregular heartbeat, respiratory depression, and other serious complications. Abnormal sodium levels cause central nervous system disturbances and water balance problems. Abnormal chloride levels can lead to acid-base disturbances affecting breathing and heart function.

Inpeco has released a Technical Service Bulletin with firmware update procedures. Field Service Engineers will perform the firmware upgrade on affected systems. A formal investigation is underway to identify the root cause and prevent future recurrences.

The recalled product

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
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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