Recall Z-1303-2024— Beckman Coulter, Inc.

Name: FDA recall Z-1303-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-08

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2024-02-08. It names one FDA 510(k) clearance: K023369. Product: Access Total T4, REF 33800, IVD, thyroxine reagent assay.. Reason: Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-08
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K023369 — ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.·cleared 2002-12-09

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 Total T4, REF 33800, IVD, thyroxine reagent assay.

Reason for recall

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

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