Becton Dickinson & Co.: Device Recall
Recall #Z-0484-2026 · 10/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0484-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Becton Dickinson & Co.
- Status
- Ongoing
- Date Initiated
- 10/23/2025
- Location
- Sparks, MD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,760 units
Reason for Recall
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.
Product Description
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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.
Other Recalls by Becton Dickinson & Co.
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
- Class II: Risk 09/23/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.