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U.S. Department of Health and Human Services

Class 2 Device Recall MULTIGENT Creatinine (Enzymatic) Assay

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  Class 2 Device Recall MULTIGENT Creatinine (Enzymatic) Assay see related information
Date Initiated by Firm May 22, 2017
Date Posted June 27, 2017
Recall Status1 Terminated 3 on September 04, 2018
Recall Number Z-2867-2017
Recall Event ID 77405
510(K)Number K073634  
Product Classification Enzymatic method, creatinine - Product Code JFY
Product MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems
The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
Code Information Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)
Recalling Firm/
Manufacturer		 Sentinel CH SPA
Via Robert Koch 2
Milan Italy
Manufacturer Reason
for Recall		 Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Sentinel Diagnostics notified the US Distributor on 5/22/17 to notify US customers by letter. Actions to be Taken 1. Discontinue the use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to your laboratory procedures. 2. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. 3. Please review the content of this communication with your Medical Director and retain this letter for any future reference. Questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT. Customers to complete Field Safety Notice Receipt.
Quantity in Commerce 2356 kits Worldwide; US 206 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 = JFY and Original Applicant = SENTINEL CH. SpA
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