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

FDA device recall Z-0431-2011 · posted 2010-11-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

CDZ

Quantity affected

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

Date initiated

2010-07-26

Date posted

2010-11-22

Date terminated

2012-05-04

Location

Brea, CA

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