Z-2251-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 2, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
Reason for Recall
In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of NC, ND, SC, TN. The countries of United Kingdom, France, New Zealand, Pakistan, Turkey.
Code Information
All serial numbers in the field