Inpeco FlexLab Automation System Recalled for Delayed Safety Switch Activation
Inpeco S.A. is recalling 10 FlexLab Automation Systems because safety switch sensors may activate with a delay of up to 2 seconds instead of the expected 40 milliseconds.
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: The recall is classified as FDA Class II, and the hazard involves a safety switch delay in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Inpeco S.A. is recalling 10 units of the FlexLab Automation System, a modular laboratory system designed to automate pre-analytical and post-analytical sample processing. The recall involves specific modules including High Volume Storage, HSQ Interface, Aliquoter, and various other interface and transportation modules.
The recall is due to a defect in the sensors that activate the safety switches. In 1% of cases, these sensors may experience a delayed activation of up to 2 seconds, rather than the 40 milliseconds expected by design. This delay could potentially compromise the safety functions of the system.
The affected products were distributed to laboratories in Illinois and New York. The specific serial numbers for the recalled units are FLX.0133, FLX.0191, FLX.0192, FLX.0197, FLX.0198, FLX.0201, FLX.0202, FLX.027, FLX.0200, and FLX.0181. Users should contact Inpeco S.A. for instructions on how to address this issue.
The recalled product
- Product
- FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Ad
- Manufacturer
- Inpeco S.A.
- Hazard
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 2 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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