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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems PROGESTERONE

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  Class 2 Device Recall Access Immunoassay Systems PROGESTERONE see related information
Date Initiated by Firm February 17, 2010
Date Posted September 29, 2010
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-2620-2010
Recall Event ID 55188
510(K)Number K955769  
Product Classification Progesterone Radioimmunoassay Systems - Product Code JLS
Product Access Immunoassay Systems PROGESTERONE, Part Number: 33550
Code Information Lot Numbers: 913013 and 914457
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall		 The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I
FDA Determined
Cause 2		 Other
Action Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed : (1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828; (3) Outside of the United States and Canada, contact your local Beckman Coulter Representative. If consignees need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.
Quantity in Commerce 6412
Distribution United States & 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 = JLS and Original Applicant = BIO-RAD LABORATORIES, INC.
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