Recall Z-0047-2013— Beckman Coulter Inc.

Name: FDA recall Z-0047-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-24

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-07-24, terminated 2013-10-17. It names one FDA 510(k) clearance: K111952. Product: Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems. Reason: Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-24
Terminated: 2013-10-17
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111952 — ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033Beckman Coulter, Inc.·cleared 2011-08-19

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 Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems

Reason for recall

Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

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