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BD Kiestra" Isolate Suspension Cuvette Array recallZ-0484-2026 · Becton Dickinson & Co. · initiated Oct 23, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0484-2026
Status
Open, Classified
Initiated by the company
Oct 23, 2025
Posted by the FDA
Nov 7, 2025
Recalling firm
Becton Dickinson & Co.
Quantity
29,760 units
Product code
LIB
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.

Product description

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

Code information (models, lots, serial numbers)

Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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