# FDA recall Z-0818-2020

> **Greiner Bio-One North America, Inc.** · Class II · device recall initiated 2019-11-25.

## Product

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

## Reason for recall

The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area.  This may lead to a vacuum loss and tubes not filling up to the proper volume.

## Distribution

Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA

## Key facts

- **Recall number:** Z-0818-2020
- **Recalling firm:** Greiner Bio-One North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-25
- **Report date:** 2020-01-29
- **Termination date:** 2020-10-05

- **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-0818-2020

## Citation

> AI Analytics. FDA recall Z-0818-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-0818-2020. Source: US FDA. Licensed CC0.

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