—#97871

Product

DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.

FDA product code: JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K921534
Affected lot / code info: Lot numbers: 991112, 991346, 991584, 991857, 992115, 992359, 992458, 992854 were manufactured at: Beckman Coulter, Diagnostics Systems Laboratories, a Beckman Coulter Company, 445 West Medical Center Blvd, Webster, Texas 77598. Lot numbers: 100115A, 100205A, 100205RA, 100226A, 100226RA, 100319A, 100319RA, 100409A, 100409RA, 100430A, 100430RA, 100521A, 100611A, 100611RA, 100702A, 100723A, 100723B, 100723RA, 100813A, 100813RB, 100813C were manufactured at: Immunotech, Prague, a Beckman Coulter Company, Radiova 1, Praha, 10227, Czech Republic.

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples.

Root cause (FDA determination)

Process control

Action the firm took

Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return. Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

Timeline

Recall initiated: 2010-09-09
Posted by FDA: 2011-07-26
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97871. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.