# FDA recall Z-0093-2025

> **Beckman Coulter, Inc.** · Class III · device recall initiated 2024-07-16.

## Product

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

## Reason for recall

Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0093-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-16
- **Report date:** 2024-10-23

- **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-0093-2025

## Citation

> AI Analytics. FDA recall Z-0093-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0093-2025. Source: US FDA. Licensed CC0.

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