Recall Z-1387-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1387-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-06

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-02-06. It names one FDA 510(k) clearance: K221225. Product: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278. Reason: Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-06
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.·cleared 2022-11-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Reason for recall

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.