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Recall Observatory FDA recall evidence

Device product

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.

Z-2251-2020

April 02, 2020

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 85449
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2251-2020

Official wording

Reason: 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.

Code information: All serial numbers in the field

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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