# FDA recall Z-0761-2020

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2019-10-16.

## Product

i-STAT cTnI cartridge

## Reason for recall

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.

## Distribution

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

## Key facts

- **Recall number:** Z-0761-2020
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-16
- **Report date:** 2020-01-08
- **Termination date:** 2020-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2020

## Citation

> AI Analytics. FDA recall Z-0761-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0761-2020. Source: US FDA. Licensed CC0.

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