Recall Z-0407-2017— Beckman Coulter Inc.

Name: FDA recall Z-0407-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-24

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2016-10-24, terminated 2018-02-01. It names one FDA 510(k) clearance: K994278. Product: Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.. Reason: Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-24
Terminated: 2018-02-01
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.·cleared 2000-03-28

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 Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.

Reason for recall

Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.

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