Recall Z-0265-2025— Beckman Coulter, Inc.

Name: FDA recall Z-0265-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-05

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2024-09-05. It names one FDA 510(k) clearance: K112933. Product: Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.. Reason: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-05
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K112933 — ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.·cleared 2011-12-27

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

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

Reason for recall

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

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