Recall Z-2638-2017— Beckman Coulter Inc.

Name: FDA recall Z-2638-2017
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: K033038. Product: Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687. 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

K033038 — GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688Beckman Coulter, Inc.·cleared 2003-12-29

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-GI Monitor (CA19-9), A83873D, Catalog No. 387687

Reason for recall

The Access immunoassays are susceptible to biotin interference.

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