Z-0431-2011

Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The...

Name: Z-0431-2011 Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The...
Creator: Beckman Coulter Inc.
Published: 2010-07-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-07-26 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a paramagnetic particle... on 2010-07-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0431-2011
Status: Terminated
Initiated: 2010-07-26
Posted: 2010-11-22
Terminated: 2012-05-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
Root cause tag: labeling and UDI
FDA root cause: Pending
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
Product codes and lots: Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628, 917613, 919184

Product code CDZ

K083867Class IAccess Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone BindBeckman Coulter, Inc. / cleared 2009-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)