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U.S. Department of Health and Human Services

Class 2 Device Recall ARIES System

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  Class 2 Device Recall ARIES System see related information
Date Initiated by Firm April 19, 2017
Create Date May 16, 2017
Recall Status1 Terminated 3 on October 20, 2017
Recall Number Z-2094-2017
Recall Event ID 77052
510(K)Number K151917  K160517  K162772  
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product ARIES System and ARIES M1 System
Code Information ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact Luminex Customer Experience Team
877-785-2323
Manufacturer Reason
for Recall		 The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.
Quantity in Commerce 15 units
Distribution Worldwide Distribution - US Distribution and to the countries of Finland and China.
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 = OOI and Original Applicant = LUMINEX CORPORATION
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