Recall Z-0239-2016— Beckman Coulter Inc.

Name: FDA recall Z-0239-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-13

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2015-10-13, terminated 2016-04-13. It names one FDA 510(k) clearance: K031270. Product: Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.. Reason: Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-13
Terminated: 2016-04-13
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.·cleared 2003-05-06

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 CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

Reason for recall

Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

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