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U.S. Department of Health and Human Services

Class 2 Device Recall ARIES HSV 1&2 Assay

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 Class 2 Device Recall ARIES HSV 1&2 Assaysee related information
Date Initiated by FirmApril 16, 2021
Create DateJanuary 14, 2022
Recall Status1 Terminated 3 on September 20, 2024
Recall NumberZ-0498-2022
Recall Event ID 89303
510(K)NumberK161495 
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductARIES HSV 1&2 Assay, Part Number/REF 50-10017
Code Information Lot number AB1703A
FEI Number 3002524000
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
512-219-8020
Manufacturer Reason
for Recall		Impacted lot may leak inside the ARIES instrument.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April 26th, 2021. We appreciate your assistance with this matter. Please call Luminex's Global Support Services if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U .S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) support@luminexcorp.com CAN-0282, Rev A
Quantity in Commerce296 kits
DistributionWorldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
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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