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.
What this means for you
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 a potential firmware issue without reported patient harm. The hazard is potential sample misidentification leading to incorrect electrolyte test results. Per the rubric, risk-of-harm products where injury has not yet been reported qualify as High (3).
Plain-English summary
Inpeco S.A. is recalling Input Output Module (IOM) FLX-201 laboratory automation systems sold under the brand names FlexLab, Accelerator a3600, and Aptio Automation. The recall affects 245 systems distributed in the US and 40+ countries worldwide.
A firmware bug may cause sample misidentification under specific timing conditions. When the module releases a sample tube just as another sample fails to divert properly, the module may incorrectly identify which sample is which. This miscommunication between firmware and automation software can cause one patient's sample to be processed under a different patient's test orders, without any error message alerting the laboratory.
Incorrect electrolyte (sodium, potassium, chloride) test results could lead to inappropriate treatment of normal results or failure to treat abnormal results. Abnormal potassium levels can cause weakness, increased urination, intestinal paralysis, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can cause neurological disturbances and water-balance problems. Abnormal chloride levels can cause acid-base disturbances that affect respiration and heart function.
Inpeco has released a firmware update (GWC board version 2-3-0 or later) to correct the issue. Laboratories should contact Inpeco to schedule the firmware update, which will be performed by Inpeco Field Service Engineers.
The recalled product
- 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
- Manufacturer
- Inpeco S.A.
- Hazard
- sample-misidentification
- incorrect-test-results
Distribution
Distributed nationwide across the United States.
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