—#90289

Product

Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K973743
Affected lot / code info: Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)

Why it was recalled

The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. The following product replacement contacts were provided: In the United States, please contact Client Services at 1-800-526-3821. In Canada, please contact Customer Service at 1-800-463-7828. Outside the United States and Canada, contact your local Beckman Coulter Representative. Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia

Timeline

Recall initiated: 2010-03-04
Posted by FDA: 2010-11-23
Terminated: 2012-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.