# FDA recall Z-0408-2026

> **Greiner Bio-One North America, Inc.** · Class II · device recall initiated 2025-08-08.

## Product

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

## Reason for recall

Blood collection tubes  were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0408-2026
- **Recalling firm:** Greiner Bio-One North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-08
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monroe, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2026

## Citation

> AI Analytics. FDA recall Z-0408-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0408-2026. Source: US FDA. Licensed CC0.

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