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U.S. Department of Health and Human Services

Class 2 Device Recall Cortisol Saliva Luminescence Immunoassay

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  Class 2 Device Recall Cortisol Saliva Luminescence Immunoassay see related information
Date Initiated by Firm January 12, 2018
Create Date August 24, 2018
Recall Status1 Terminated 3 on June 02, 2020
Recall Number Z-2923-2018
Recall Event ID 80554
510(K)Number K150528  
Product Classification Enzyme immunoassay, cortisol, salivary - Product Code NHG
Product Cortisol Saliva Luminescence Immunoassay

The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
Code Information In USA RE62119 Lot # LCL129 exp. date: 2017-11-30,  RE62119 Lot # LCL133 exp. date: 2019-03-31, and  RE62111 Lot # LCL130 exp. date: 2018-03-31. OUS  Lot 131, Lot 132    
Recalling Firm/
Manufacturer		 Tecan US, Inc.
9401 Globe Center Dr Ste 140
Morrisville NC 27560-6211
For Additional Information Contact Conatc your Local Tecan Helpdesk or IBL
919-361-5200
Manufacturer Reason
for Recall		 Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, IBL International, sent an "Urgent Field Corrective Action" letter dated 1/12/2018 via registered mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine your stock and affected lots; contact all customers and provide the letter; if you have any of the affected product, stop using and quarantine/scrap all remaining product from lots LCL129 up to LCL 133. Review results generated with affected lots and follow your laboratory standard operational procedures to review any potential aberrant results that may have occurred; complete and return the Customer Response Form by fax to:1-919-287-2961; email to:QA@tecan.com or mail to: Attention: Tecan QA, 9401 Globe Center Dr., Suite 140, Morrisville, North Carolina 27560,United States to confirm receipt and actions. The firm is expect to have a new lot of Cortisol Saliva LUM available to ship by the end of February 2018. if you have any questions, please contact your local Tecan Helpdesk or IBL or Sr. Director Global Regulatory Affairs at 919-943-7118 or email: Laura.nea@tecan.com.
Quantity in Commerce 870 (USA) 180 (OUS)
Distribution Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
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 = NHG and Original Applicant = IBL INTERNATIONAL GMBH
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