Recall Z-1833-2017— Beckman Coulter Inc.

Name: FDA recall Z-1833-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-10

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-03-10, terminated 2017-06-27. It names 2 FDA 510(k) clearances: K052082, K926221. Product: Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C. Reason: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-10
Terminated: 2017-06-27
Firm location: Brea, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.·cleared 2005-08-19
K926221 — ACCESS FERRITIN ASSAYBio-Rad Laboratories, Inc.·cleared 1993-01-13

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 Ferritin Calibrators, Part No. 33025, Ref No. B50136C

Reason for recall

Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

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