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U.S. Department of Health and Human Services

Class 2 Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent

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  Class 2 Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent see related information
Date Initiated by Firm July 26, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on May 04, 2012
Recall Number Z-0431-2011
Recall Event ID 56416
510(K)Number K083867  
Product Classification Radio immunoassay, tetosterone and dihydrotestosterone - Product Code CDZ
Product Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
Code Information Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628,  917613, 919184
Recalling Firm/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. ODonovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be used when calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values and Access Testosterone (ng/mL) values are reported in different default units. The testosterone value (when reported in ng/mL) requires conversion to nmol/L before the FAI % can be calculated.
FDA Determined
Cause 2
Action Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter on the week of July 26, 2010 to the affected customers. The letter was dated July 30, 2010, and identified the product, the problem and provided the appropriate equation to recalculate the FAI% values. The customers were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were also asked to complete and return the enclosed response form within 10 days to confirm that they had received the important notification. The customers were instructed to contact Beckman Coulter Technical Support at 1-800-854-3633 in the United States, or contact their local Beckman Coulter Representative if they had any questions regarding the notification.
Quantity in Commerce 1,113 Units ( 894 in US & 219 in Canada)
Distribution Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CDZ and Original Applicant = BECKMAN COULTER, INC.