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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 FirmNovember 17, 2021
Create DateFebruary 02, 2022
Recall Status1 Terminated 3 on July 08, 2024
Recall NumberZ-0553-2022
Recall Event ID 89244
510(K)NumberK161495 
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Code Information Lot Numbers AB3600A and AB3560A
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. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 11/17/2021, the firm notified affected customers via letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated, if you observe any leaks, please contact Luminex Global Support Services at support@luminexcorp.com. Please inform all those who need to be aware within your organization of this potential product performance issue. Please contact Luminex Global Support Services at support@luminexcorp.com at your earliest convenience if you have a Kit with an affected lot to arrange for its replacement, and to confirm the disposal of any remaining Kits in your inventory. We ask that you complete and return the attached acknowledgement letter so that we can confirm the destruction of recalled lots. Luminex Global Support Services, 1-877-785-2323 (U.S. and Canada}, +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com
Quantity in Commerce329
DistributionWorldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
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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