BD Kiestra" Isolate Suspension Cuvette Array recall
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Why was BD Kiestra" Isolate Suspension Cuvette Array recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;
- Product
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 29,760 units
- 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.
- Recall date
- November 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)