# FDA recall Z-0399-2022

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-11-10.

## Product

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

## Reason for recall

Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

## Distribution

US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland, Arizona, Hawaii, Missouri, Oregon, Mississippi, Rhode Island, Alaska, Tennessee, Illinois, Delaware, Kentucky, Arkansas, West Virginia, Massachusetts.  OUS: India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, Thailand

## Key facts

- **Recall number:** Z-0399-2022
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-10
- **Report date:** 2021-12-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2022

## Citation

> AI Analytics. FDA recall Z-0399-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0399-2022. Source: US FDA. Licensed CC0.

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