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Recall Observatory FDA recall evidence

Device product

Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

Z-2404-2020

May 07, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 85687
Status
Ongoing
Classification
Class II
Quantity
927
Official record key
device-enforcement:Z-2404-2020

Official wording

Reason: Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.

Code information: Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL

Distribution pattern: Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.