Recall Z-0572-2013— Beckman Coulter Inc.

Name: FDA recall Z-0572-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-11-05, terminated 2014-05-14. It names one FDA 510(k) clearance: K940549. Product: The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.. Reason: Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif.

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Terminated: 2014-05-14
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K940549 — ACCESS(R) HUMAN LUTEINZING HORMONE ASSAYBio-Rad Laboratories, Inc.·cleared 1994-04-06

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

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.

Reason for recall

Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif

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