—#216646

Product

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

FDA product code: LIB — Device, General Purpose, Microbiology, Diagnostic
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666;

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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.

Timeline

Recall initiated: 2025-10-23
Posted by FDA: 2025-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.