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Recall Observatory FDA recall evidence

Device product

Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

Z-1888-2020

April 07, 2020

Class II

Product summary

Firm
Inpeco S.A.
Event
Event 85429
Status
Ongoing
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-1888-2020

Official wording

Reason: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

Code information: Serial Numbers: ACP.357, ACP.388, ACP.396, ACP.397, ACP.399, ACP.400, ACP.402, ACP.404, ACP.405, ACP.407, ACP.408, ACP.409, ACP.410, ACP.412, ACP.413, ACP.416, ACP.417, ACP.418, ACP.419, ACP.420, ACP.421, ACP.422, ACP.423

Distribution pattern: Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.