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Recall Observatory FDA recall evidence

Device product

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

Z-0484-2026

October 23, 2025

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 97817
Status
Ongoing
Classification
Class II
Quantity
29,760 units
Official record key
device-enforcement:Z-0484-2026

Official wording

Reason: 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.

Code information: Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.