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U.S. Department of Health and Human Services

Class 2 Device Recall Urea Nitrogen (UN) Reagent Kit

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 Class 2 Device Recall Urea Nitrogen (UN) Reagent Kitsee related information
Date Initiated by FirmMarch 27, 2018
Create DateJune 04, 2018
Recall Status1 Terminated 3 on February 03, 2021
Recall NumberZ-2062-2018
Recall Event ID 79932
510(K)NumberK991576 
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
ProductADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Code Information Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
FDA Determined
Cause 2		Material/Component Contamination
ActionDate recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.
DistributionNationwide and worldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CDQ
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