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.
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 potential incorrect clinical results which poses a risk of harm to patients, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Inpeco S.A. is recalling the Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module and Track to Rack Module, known as the FlexLab 3.6 Automation. 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, specifically for clinical chemistry tests such as sodium, potassium, and chloride measurements.
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 could result in incorrect or delayed test results. The affected serial numbers are ACP.413 and ACP.424 in the US, and ACP.349, ACP.399, ACP.400, ACP.410, ACP.252, and ACP.290 outside the US.
The products were distributed worldwide, including in the US states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, and VA, as well as in Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, the Netherlands, Norway, Saudi Arabia, South Korea, Sweden, and the United Arab Emirates. Healthcare facilities and laboratories should contact Inpeco S.A. for instructions on how to address the firmware issue.
The recalled product
- 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…
- 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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