FDA Medical devices recall ·
BD Kiestra" Isolate Suspension Cuvette Array recall
- Recall number
- Z-0484-2026
- Date
- (initiated October 23, 2025)
- Company / brand
- Becton Dickinson & Co.
7 Loveton Cir, Sparks, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29,760 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Colorado Connecticut Kentucky New Jersey Tennessee Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0484-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.