# FDA recall Z-2115-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-02-27.

## Product

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

## Reason for recall

Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850.  The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

## Distribution

International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland

## Key facts

- **Recall number:** Z-2115-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2025-02-27
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2025

## Citation

> AI Analytics. FDA recall Z-2115-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2115-2025. Source: US FDA. Licensed CC0.

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