# FDA recall Z-0889-2026

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-11-07.

## Product

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

## Reason for recall

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-0889-2026
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-07
- **Report date:** 2025-12-17

- **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-0889-2026

## Citation

> AI Analytics. FDA recall Z-0889-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0889-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*