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U.S. Department of Health and Human Services

Class 2 Device Recall Access Cortisol Reagent Assay

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  Class 2 Device Recall Access Cortisol Reagent Assay see related information
Date Initiated by Firm September 18, 2018
Create Date September 30, 2019
Recall Status1 Terminated 3 on February 21, 2024
Recall Number Z-2763-2019
Recall Event ID 83163
510(K)Number K050202  K023764  
Product Classification Radioimmunoassay, cortisol - Product Code CGR
Product The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Code Information Lot Number 831755.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Customer Technical Support
800-854-3633
Manufacturer Reason
for Recall		 Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
FDA Determined
Cause 2		 Process design
Action An Urgent Medical Device Recall Letter was sent during the week of 9/17/2018 to all affected customers via mail and or email. Customers were instructed to discontinue use and discard remaining product. Customers were also instructed to consider a review of the Cortisol results generated with the affected lot number at the discretion of the Medical Director.
Quantity in Commerce Access Cortisol Reagent Assay
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
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 = BECKMAN COULTER, INC.
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