Z-2003-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 7, 2020
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82
Product Description
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.
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.
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
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