FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Recall Z-0432-2021 · Posted None
Advertisement
Recalling FirmInpeco S.A.
Recall StatusTerminated
Product CodeCEM
Date Initiated2020-07-14
Date Terminated2023-12-28
Product Quantity93
Reason for Recall
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is
flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Firm Action
The firm, inpeco, sent "Urgent: Medical Device Correction" letters dated 7/14/20 to its customers. The letter described the product, problem and actions to be taken.
Action to be taken by the user:
Be aware that the Secondary Sample Tube flagged with error 2132 or 1442 may be diluted: discard this Secondary Sample Tube or manage it according to your laboratory guidelines.
Your service provider will contact you to schedule the upgrade of the software driver and language.ini with the new error message and error recovery displayed if error 2132 or 1442 occurs.
Until the service visit please maintain awareness on this notice.
Please transfer this notice to whom it might concern.
Please complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to the email address specified in the email communication.
Contact reference person:
For any clarification you may need, do not hesitate to contact:
Eva Balzarotti - Regulatory Affairs Manager
E-mail: [email protected]
Phone: (+41) 919118 224
Root Cause
Software design
Distribution Pattern
Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement