FDA-Device2020-01-08Class II
i-STAT cTnI cartridge
Abbott Point Of Care Inc.
Hazard
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.
Sold states
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
Affected count
3,465,875
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
i-STAT cTnI cartridge
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2020Don't want to check this manually?
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