FDA recall Z-0484-2026

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2025-10-23

Report date

2025-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2026