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Recall Observatory FDA recall evidence

Device product

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.

Z-2003-2020

April 07, 2020

Class II

Product summary

Firm
Inpeco S.A.
Event
Event 85454
Status
Terminated
Classification
Class II
Quantity
82
Official record key
device-enforcement:Z-2003-2020

Official wording

Reason: When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Code information: Serial Numbers: AML.001, FLX.0104, FLX.0105, FLX.0106, FLX.0107, FLX.0108, FLX.0112, FLX.0114, FLX.0115, FLX.0116, FLX.0118, FLX.0119, FLX.0120, FLX.0124, FLX.0125, FLX.0126, FLX.0131, FLX.0133, FLX.0134, FLX.0135, FLX.0136, FLX.0140, FLX.0141, FLX.0142, FLX.0143, FLX.015, FLX.0152, FLX.0155, FLX.0158, FLX.0161, FLX.0163, FLX.0164, FLX.017, FLX.0175, FLX.0178, FLX.018, FLX.0184, FLX.0189, FLX.019, FLX.0196, FLX.020, FLX.021, FLX.023, FLX.026, FLX.027, FLX.030, FLX.032, FLX.033, FLX.038, FLX.040, FLX.044, FLX.045, FLX.047, FLX.051, FLX.052, FLX.053, FLX.054, FLX.055, FLX.058, FLX.059, FLX.063, FLX.064, FLX.065, FLX.066, FLX.067, FLX.068, FLX.071, FLX.072, FLX.074, FLX.075, FLX.076, FLX.077, FLX.079, FLX.080, FLX.081, FLX.091, FLX.092, FLX.095, FLX.099, FLX.101, FLX.102, FLX.103

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.