Recall Z-0484-2026— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2025-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;. Reason: 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-23
- Firm location
- Sparks, MD, United States
Product description
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.