—#93491

Product

Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.

FDA product code: CGF — Radioimmunoassay, Estrone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K935013
Affected lot / code info: Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA

Why it was recalled

Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions: *For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications. *For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the light of additional applicable tests, patient's clinical status and clinical history of patient. Beckman Coulter has finalized the process of re-adjusting Estrone calibrators' values assignment to the new internal reference calibrator starting with lot 100403A. If consignees need products for additional tests they were told to follow replacement instructions below: *In the United States, please contact Customer Service at 1-800-526-3821 *Outside the United States, contact your local Beckman Coulter Representative. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They were to also complete and return the enclosed response form within 10 days so the firm can be assured that consignees received the notification. Consignees were instructed to forward any other questions regarding the notification to the DSL Technical Support Center at 1-800-231-7970 in the United States, or 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 -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.

Timeline

Recall initiated: 2010-04-22
Posted by FDA: 2011-03-17
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.