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.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect or delayed diagnostic results) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Inpeco S.A. is recalling the FlexLab (FLX) laboratory automation system, which includes the Sysmex XN-9000/XN-9100 Interface Module and the Track to Rack Module. The recall involves 2 units in the United States and 6 units outside the United States. The affected systems are used to automate pre-analytical and post-analytical sample processing in clinical laboratories.
The recall is due to a firmware defect in the Sysmex XN-9000/XN-9100 Interface Module and the Track to Rack Module. This defect has the potential to mis-associate sample IDs, which can result in incorrect test results or delayed results. The systems are used to process samples for assays such as Sodium, Potassium, and Chloride measurements, which are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
The affected units were distributed nationwide in the United States, including in Alaska, Florida, Iowa, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, Ohio, Texas, and Virginia. They were also distributed in Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, the Netherlands, Norway, Saudi Arabia, South Korea, Sweden, and the United Arab Emirates. Affected serial numbers include FLX.0133 and FLX.0181 in the US, and FLX.0048, FLX.0049, FLX.0121, FLX.0155, FLX.0160, and FLX.0200 outside the US. Healthcare facilities should contact Inpeco S.A. for instructions on how to address the firmware issue.
The recalled product
- 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…
- Manufacturer
- Inpeco S.A.
Distribution
Part of a larger recall action
This product is one of 3 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.
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