Z-0484-2026Class II

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

Name: Z-0484-2026 BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100
Creator: Becton Dickinson & Co.
Published: 2025-10-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-10-23 / Open, Classified / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100 on 2025-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0484-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-23
Posted: 2025-11-07
Recalling firm: Becton Dickinson & Co
Product: BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0484-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code LIB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)