# FDA recall Z-0071-2026

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-09-03.

## Product

SYNCHRON Systems Phosphorus (PHOSm) Reagent  REF: 467868  For In Vitro Diagnostic Use, Rx Only.

## Reason for recall

Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

## Distribution

US: AL	KY	LA	MA	MD	MS	NC	NE	NJ	NY	OK	PA	TX	WA	WV OUS: Canada Mexico Singapore

## Key facts

- **Recall number:** Z-0071-2026
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-10-15

- **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-0071-2026

## Citation

> AI Analytics. FDA recall Z-0071-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0071-2026. Source: US FDA. Licensed CC0.

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