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Recall Observatory FDA recall evidence

Device product

i-STAT cTnI cartridge

Z-0761-2020

October 16, 2019

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 84166
Status
Terminated
Classification
Class II
Quantity
3,465,875
Official record key
device-enforcement:Z-0761-2020

Official wording

Reason: i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

Code information: List Number: 06P23-25 UDI: (01)00054749001986

Distribution pattern: US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.