FlexLab Automation System used with the following Modules... (Inpeco S.A. Via San Gottardo 10 Lugano Switzerland) – the sensors which activate the safety... (2020)
Safety switch sensors may have delayed activation response.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Prod
Brand
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: FLX.0133 FLX.0191 FLX.0192 FLX.0197 FLX.0198 FLX.0201 FLX.0202 FLX.027 FLX.0200 FLX.0181
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland is recalling FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, due to The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
Recommended Action
Per FDA guidance
Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. Action to be taken by the user After module protection removal, wait at least 2 seconds before accessing the impacted module (listed in Table 1). Your service provider will contact you to replace the sensor. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this notice to whom it might concern. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatorv.Affairs@inpeco.com Phone: (+41) 919118 224
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, NY
Page updated: Jan 10, 2026