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U.S. Department of Health and Human Services

Class 2 Device Recall Active Cortisol EIA

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  Class 2 Device Recall Active Cortisol EIA see related information
Date Initiated by Firm July 20, 2009
Date Posted July 08, 2011
Recall Status1 Terminated 3 on April 27, 2012
Recall Number Z-2761-2011
Recall Event ID 55227
510(K)Number K884689  
Product Classification Radioimmunoassay, cortisol - Product Code CGR
Product Active Cortisol EIA, 96 Wells, DSL-10-2000

The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.
Code Information Lot Numbers Epiration Dates 04195 8/15/2006 04195A 10/18/2006 04195B 1/26/2006 04195D 8/15/2006 04195E 10/18/2006 04195F 10/18/2006 09266A 01/31/2006 09266 10/17/2007 04126A 10/11/2007 04126 7/28/2007 03066A 09/05/2007 03066 09/05/2007 01036 07/02/2007 716217 06/06/2008 716218 07/29/2008 800408 05/07/2009 800409 05/07/2009 800410 05/07/2009 890829 09/03/2009 990168 09/03/2009   
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica
FDA Determined
Cause 2		 Other
Action Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below. Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification. Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.
Quantity in Commerce 1369 Kits
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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 = CGR and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.
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