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U.S. Department of Health and Human Services

Class 2 Device Recall Sentinel MULTIGENT Ammonia Ultra Reagent

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  Class 2 Device Recall Sentinel MULTIGENT Ammonia Ultra Reagent see related information
Date Initiated by Firm September 22, 2015
Date Posted October 26, 2015
Recall Status1 Terminated 3 on March 30, 2016
Recall Number Z-0164-2016
Recall Event ID 72311
510(K)Number K051114  
Product Classification Enzymatic method, ammonia - Product Code JIF
Product Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Code Information Lot 50083Y600, expiration date 31 Jul 2016.
Recalling Firm/
Manufacturer		 Sentinel CH SpA
Via Robert Koch 2
Milano Italy
Manufacturer Reason
for Recall		 Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
FDA Determined
Cause 2		 Process control
Action Sentinel Urgent Field Safety Notice issued on 9/22/15 by Abbott to customers, including their US customers. Actions to be Taken 1. Immediately discontinue use of lot 50083Y600 and destroy any remaining inventory. 2. Order a replacement Ammonia Ultra reagent lot. 3. Follow your individual laboratory protocol regarding reviewing previously reported patient results. 4. Please retain this communication for future reference. If you have forwarded any MULTIGENT Ammonia Ultra reagent lot 50083Y600 to another laboratory, please provide a copy of this letter to them. Contacts If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT.
Quantity in Commerce 765 kits
Distribution Nationwide Distribution.
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 = SENTINEL CH. SRL
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