BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

FDA device recall Z-0484-2026 · posted 2025-11-07 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

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.

Action taken

On October 23, 2025 URGENT: Medical Device Correction letters were sent to customers. Actions for Clinical Users: 1. Immediately inspect your inventory for the specific catalog and lot numbers listed to determine if the lot in your possession is impacted and immediately discard any remaining inventory of the affected product. 2. *Note: Lot LM245666 has undergone rework and will be used as replacement material for affected product. Reworked inventory from this lot can be identified using the indicators described in ATTACHMENT 1- How to Identify Affected vs Reworked Product. Action to be taken by customer 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LIB

Quantity affected

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.

Date initiated

2025-10-23

Date posted

2025-11-07

Location

Sparks, MD