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U.S. Department of Health and Human Services

Class 2 Device Recall Ammonia L3K Assay

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  Class 2 Device Recall Ammonia L3K Assay see related information
Date Initiated by Firm November 29, 2016
Date Posted January 23, 2017
Recall Status1 Terminated 3 on July 06, 2017
Recall Number Z-1078-2017
Recall Event ID 75818
510(K)Number K033921  
Product Classification Enzymatic method, ammonia - Product Code JIF
Product Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10
For the IN VITRO quantitative measurement of ammonia concentration in plasma
Code Information Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
Recalling Firm/
Manufacturer		 Sekisui Diagnostics P.E.I. Inc.
70 Watts Ave
Charlottetown Canada
For Additional Information Contact
800-565-0265
Manufacturer Reason
for Recall		 Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
FDA Determined
Cause 2		 Material/Component Contamination
Action Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K¿ reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK¿ from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.
Quantity in Commerce 774 Liters bulk and 565 kits
Distribution Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
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 = JIF and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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