FDA DeviceClass II

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

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.

From the FDA notice · Read the official notice ↗ · All Becton Dickinson recalls

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Product
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
29,760 units
Illnesses reported
None reported
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Classification
Class II
Recall number
Z-0484-2026

In the FDA's words

Description
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; 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. Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666; 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. Affected quantity: 29,760 units
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.

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