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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 Systemsee related information
Date Initiated by FirmApril 19, 2017
Create DateMay 16, 2017
Recall Status1 Terminated 3 on October 20, 2017
Recall NumberZ-2094-2017
Recall Event ID 77052
510(K)NumberK151917 K160517 K162772 
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductARIES 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 ContactLuminex 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
ActionA 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 Commerce15 units
DistributionWorldwide Distribution - US Distribution and to the countries of Finland and China.
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 = OOI
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