# FDA recall Z-0484-2026

> **Becton Dickinson & Co.** · Class II · device recall initiated 2025-10-23.

## Product

BD Kiestra" Isolate Suspension Cuvette Array;  Catalog No.: 246100;

## Reason for recall

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

## Distribution

Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.

## Key facts

- **Recall number:** Z-0484-2026
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-23
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2026

## Citation

> AI Analytics. FDA recall Z-0484-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0484-2026. Source: US FDA. Licensed CC0.

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