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Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
• Repeat samples with cTnI results above 0.07 ng/mL or your institution’s established 99th percentile value
    o As mentioned above, there is a potential for false positive results when using cTnI TestPaks any time during shelf life; therefore, as an additional measure, customers are advised to perform repeat testing of samples when the cTnI result is above 0.07 ng/mL or your institution’s established 99th percentile value.
    o As recommended in the Acute Care™ cTnI TestPak Instructions for Use (IFU), a test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Furthermore, results should be interpreted as part of serial sampling at admission.
• Siemens will reimburse users for repeat tests and discarded cTnI TestPaks associated with this field corrective action. 

Manufacturer action: Instructions and removal.

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