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Recall Observatory FDA recall evidence

Device product

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.

Z-1633-2016

February 09, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 73442
Status
Terminated
Classification
Class II
Quantity
394
Official record key
device-enforcement:Z-1633-2016

Official wording

Reason: Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.

Code information: Lot # EB6064

Distribution pattern: Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.