Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

Recall date
October 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0484-2026
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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