Recall Z-0100-2024— Beckman Coulter, Inc.

Name: FDA recall Z-0100-2024
Creator: U.S. Food and Drug Administration
Published: 2023-07-06

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-07-06. It names one FDA 510(k) clearance: K031269. Product: Access Thyroglobulin Calibrators. Reason: It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-06
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.·cleared 2003-05-02

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 Calibrators

Reason for recall

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

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