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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the potential for incorrect clinical results which could impact patient care.
Plain-English summary
Inpeco S.A. is recalling Aptio Automation systems equipped with Sysmex XN-9000/XN-9100 Interface Modules and Track to Rack Modules. The recall involves 10 units in the United States and 22 units outside the United States. The affected systems are modular automation platforms used in laboratories to automate pre-analytical and post-analytical processing, including sample handling for clinical chemistry tests such as Sodium, Potassium, and Chloride.
The recall was initiated because the firmware of the Sysmex XN-9000/XN-9100 Interface Module and the Track to Rack Module has the potential to mis-associate sample IDs. This defect may lead to incorrect results or delayed results for clinical chemistry assays. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed nationwide in the United States, including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, and VA, as well as in several international markets including Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, Saudi Arabia, South Korea, Sweden, and the United Arab Emirates. Specific serial numbers for the affected units are listed in the structured product information. Users of these systems should contact Inpeco S.A. for further instructions on how to address the firmware issue.
The recalled product
- 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
- 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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