FDA-Device2025-11-19Class IIMISBRANDING
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
Affected count
29,760 units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2026Want us to check the next one for you?
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