# FDA recall Z-0777-2023

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2022-11-18.

## Product

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic  use only.

## Reason for recall

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

## Distribution

US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

## Key facts

- **Recall number:** Z-0777-2023
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-18
- **Report date:** 2023-01-11

- **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-0777-2023

## Citation

> AI Analytics. FDA recall Z-0777-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0777-2023. Source: US FDA. Licensed CC0.

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