Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) 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-2003-2020 · Posted None
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Recalling FirmInpeco S.A.
Recall StatusTerminated
Product CodeCEM
Date Initiated2020-04-07
Date Terminated2022-07-28
Product Quantity82
Reason for Recall
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Firm Action
On April 7, 2020, the firm sent an Urgent Medical Device Correction letter to all impacted customers and instructed them to return the Customer Letter Receipt Confirmation and Implementation Check form within 15 days. The customers were asked to confirm that they had read, understood, and applied all the applicable recommended actions. The impacted Customers were told that they would be contacted by their service representative to schedule the system update.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington
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.
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