Recall Z-1996-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1996-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-05-07. It names one FDA 510(k) clearance: K221225. Product: DxI 9000 Access Immunoassay Analyzer C11137. Reason: Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-07
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 C11137

Reason for recall

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

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