# FDA recall Z-0984-2022

> **Beckman Coulter, Inc.** · Class III · device recall initiated 2022-02-16.

## Product

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

## Reason for recall

IRISpec CA failures for glucose.

## Distribution

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

## Key facts

- **Recall number:** Z-0984-2022
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-16
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2022

## Citation

> AI Analytics. FDA recall Z-0984-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0984-2022. Source: US FDA. Licensed CC0.

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