Recall Z-2637-2017— Beckman Coulter Inc.

Name: FDA recall Z-2637-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-09

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-05-09, terminated 2018-03-30. It names one FDA 510(k) clearance: K982250. Product: Access System-Free T4 Assay, B01902E, Catalog No. 33880. Reason: The Access immunoassays are susceptible to biotin interference..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Terminated: 2018-03-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.·cleared 1998-07-14

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 System-Free T4 Assay, B01902E, Catalog No. 33880

Reason for recall

The Access immunoassays are susceptible to biotin interference.

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