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Abbott Point Of Care Inc. recalls i-STAT cTnI cartridge
Recalled January 8, 2020 · FDA recall Z-0761-2020 · Abbott Point Of Care
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. · FDA Class II
Units
3,465,875
Sold at
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
Description
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.
Product
i-STAT cTnI cartridge
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →