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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