FDAHealthOctober 23, 2025
Becton Dickinson & Co. — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 23, 2025
Worldwide - US Nationwide distribution in the states of CO, CT, KY, NJ, TN, TX, UT and the countries of Belgium, Singapore, Taiwan, Germany, Switzerland.
What's affected?
- Product
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
- Lot code
- LM245590
Additional details
Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 29,760 units.
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