# FDA recall Z-0571-2026

> **Greiner Bio-One North America, Inc.** · Class II · device recall initiated 2025-08-19.

## Product

Brand Name: Vacuette  Product Name: 8 ml CAT Serum Separator Clot Activator  Model/Catalog Number: 455071P  Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

## Reason for recall

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing.  This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

## Distribution

U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY.  O.U.S.: None

## Key facts

- **Recall number:** Z-0571-2026
- **Recalling firm:** Greiner Bio-One North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-19
- **Report date:** 2025-11-26

- **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-0571-2026

## Citation

> AI Analytics. FDA recall Z-0571-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0571-2026. Source: US FDA. Licensed CC0.

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