# FDA recall Z-1534-2021

> **Greiner Bio-One North America, Inc.** · Class II · device recall initiated 2021-03-29.

## Product

VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage:  indicated for use in collection and transport of venous whole blood for coagulation testing.

## Reason for recall

VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

## Distribution

US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.

## Key facts

- **Recall number:** Z-1534-2021
- **Recalling firm:** Greiner Bio-One North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-29
- **Report date:** 2021-05-12
- **Termination date:** 2023-10-10

- **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-1534-2021

## Citation

> AI Analytics. FDA recall Z-1534-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1534-2021. Source: US FDA. Licensed CC0.

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