Abbott Point Of Care Inc. recalls i-STAT cTnI cartridge
- Recall date
- October 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0761-2020
- FDA classification
- Class II
- Brand / firm
- Abbott Point Of Care Inc.
- Sold / distributed
- 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
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
i-STAT cTnI cartridge
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