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U.S. Department of Health and Human Services

Class 2 Device Recall Estrone Radioimmunoassay (RIA) Kit

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 Class 2 Device Recall Estrone Radioimmunoassay (RIA) Kitsee related information
Date Initiated by FirmApril 22, 2010
Date PostedMarch 17, 2011
Recall Status1 Terminated 3 on May 04, 2012
Recall NumberZ-1685-2011
Recall Event ID 56399
510(K)NumberK935013 
Product Classification Estrone Radioimmunoassay - Product Code CGF
ProductEstrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.
Code Information Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionBeckman 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.
Quantity in Commerce917 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CGF
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