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U.S. Department of Health and Human Services

Class 2 Device Recall Active Prolactin ELISA

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  Class 2 Device Recall Active Prolactin ELISA see related information
Date Initiated by Firm August 03, 2009
Date Posted April 20, 2011
Recall Status1 Terminated 3 on April 27, 2012
Recall Number Z-2047-2011
Recall Event ID 55154
510(K)Number K960561  
Product Classification Radioimmunoassay, prolactin (lactogen) - Product Code CFT
Product Active Prolactin ELISA, 96 Wells, DSL-10-4500

The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
Code Information Lot Number: 890291
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio
FDA Determined
Cause 2		 Equipment maintenance
Action The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: Action/Resolution: Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product. Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, they were told to contact Technical support at the phone number listed below. Consignees were asked to share this information with their laboratory staff and retain this letter for their Quality System documentation and asked to complete and return the enclosed response form within 10 days via fax to: 786-639-4000 so that Beckman can be assured that they received the notification. If you have any other questions regarding this notification, please contact DSL Technical Support Center at 1-800-231-7970 in the United States and Canada , or contact their local Beckman Coulter Representative.
Quantity in Commerce 30 Kits
Distribution Nationwide distribution: USA including states of: FL, GA and NC.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CFT and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.
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