Class II

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

Becton Dickinson & Co. · October 23, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

29,760 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0484-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Becton Dickinson & Co. Medical Device Recall: BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; | SafeCheck