COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunctio

FDA device recall Z-1221-2026 · posted 2026-01-30 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Action taken

During the week of 11/10/2025, the firm sent via postal and e-mail an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has confirmed that specific diluent lot numbers of COULTER DxH Diluent and DxH ECO Diluent may contribute to elevated platelet (PLT) Daily Checks background counts cycle when used with the UniCel DxH 600/690T/800/900 analyzers. Customers are instructed to: "Check their COULTER DxH Diluent and DxH ECO Diluent inventory against the provided affected lot numbers. "If their lot numbers are NOT affected, continue routine operation and no further action is required. "If their lot numbers are affected, perform a Daily Checks cycle. o Each container must be individually verified through Daily Checks before use according to the instructions below. o If Daily Checks pass, continue routine operation and no further action is required, on the active diluent container(s), currently in use. "If the Daily Checks cycle does not pass, follow the instruction provide in the Recall Letter. For questions or further assistance - email BECFA@beckman.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GIF

Quantity affected

76,098 units (US-61843 and OUS-14255)

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,

Date initiated

2025-11-10

Date posted

2026-01-30

Location

Miami, FL